- [Home](/) › - [DeviceEstablishmentPulse](/v/deviceestablishmentpulse) › - [Hubs](/hub/deviceestablishmentpulse) › - All record reports # DeviceEstablishmentPulse: all 1,000 record reports, page 1 of 5 Every DeviceEstablishmentPulse record report, 200 per page, grouped by state. Records 1 to 200: Nas Med LLC Fz (foreign exporter, DUBAI Dubayy, AE): 7 new FDA device listings, incl. staple, implantable to Gcmedica Enterprise Ltd.(Wuxi) (manufacturer, WUXI Jiangsu, CN): 3 new FDA device listings, incl. applicator, vaginal. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration). 1 [2](/hub/deviceestablishmentpulse/records/2) [3](/hub/deviceestablishmentpulse/records/3) [4](/hub/deviceestablishmentpulse/records/4) [5](/hub/deviceestablishmentpulse/records/5) ## AE - [Nas Med LLC Fz (foreign exporter, DUBAI Dubayy, AE): 7 new FDA device listings, incl. staple, implantable](/report/deviceestablishmentpulse/nas-med-llc-fz-dubai-dubayy-ae--fdaest-3035387162-2026-09-28) ## Alabama - [Advanced Product Solutions Inc. (contract manufacturer, Dothan, AL): 3 new FDA device listings, incl. instrument, surgical, disposable](/report/deviceestablishmentpulse/advanced-product-solutions-inc-dothan-al--fdaest-3018071447-2026-08-27) - [Curiteva, Inc. (contract manufacturer, Tanner, AL): 11 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/curiteva-inc-tanner-al--fdaest-3012131184-2026-09-04) - [Dunamis Medical LLC (manufacturer, Greenville, AL): 3 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene](/report/deviceestablishmentpulse/dunamis-medical-llc-greenville-al--fdaest-3011061237-2026-05-29) - [Elite Medical, LLC (contract manufacturer, Florence, AL): 17 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/elite-medical-llc-florence-al--fdaest-3017565094-2026-09-03) - [Rohrer Aesthetics, Inc. (other, Homewood, AL): 3 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/rohrer-aesthetics-inc-homewood-al--fdaest-3031944951-2026-09-09) - [Turner Medical Inc. (contract manufacturer, Athens, AL): 9 new FDA device listings, incl. plate, fixation, bone](/report/deviceestablishmentpulse/turner-medical-inc-athens-al--fdaest-3005706667-2026-08-05) ## Arizona - [Aesthetic Protools, Inc. (specification developer, Scottsdale, AZ): 3 new FDA device listings, incl. powered light based non-laser surgical instrument with thermal effect](/report/deviceestablishmentpulse/aesthetic-protools-inc-scottsdale-az--fdaest-3043846025-2026-08-24) - [Aurora Gp Lab Inc (contract manufacturer, Goodyear, AZ): 6 new FDA device listings, incl. lens, contact, orthokeratology, overnight](/report/deviceestablishmentpulse/aurora-gp-lab-inc-goodyear-az--fdaest-3045320731-2026-06-10) - [Bard Peripheral Vascular, Inc. (contract manufacturer, Tempe, AZ): 2 new FDA device listings, incl. shunt, portosystemic, endoprosthesis](/report/deviceestablishmentpulse/bard-peripheral-vascular-inc-tempe-az--fdaest-2020394-2026-09-28) - [Dexcom, Inc. (manufacturer, Mesa, AZ): 3 new FDA device listings, incl. integrated continuous glucose monitor for non-intensive glucose manage](/report/deviceestablishmentpulse/dexcom-inc-mesa-az--fdaest-3017425868-2026-08-10) - [Dexcom, Inc. (manufacturer, Mesa, AZ): 5 new FDA device listings, incl. tape and bandage, adhesive](/report/deviceestablishmentpulse/dexcom-inc-mesa-az--fdaest-3013435121-2026-08-10) - [Ge Parallel Design, Inc. (manufacturer, Phoenix, AZ): 19 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/ge-parallel-design-inc-phoenix-az--fdaest-2032350-2026-10-07) - [Sequitur Health Corp. (manufacturer, Phoenix, AZ): 3 new FDA device listings, incl. analyzer, chemistry (photometric, discrete), for clinical use](/report/deviceestablishmentpulse/sequitur-health-corp-phoenix-az--fdaest-3023591031-2026-09-02) ## Arkansas - [Sterigenics US LLC (contract sterilizer, West Memphis, AR): 4 new FDA device listings, incl. insufflator, laparoscopic](/report/deviceestablishmentpulse/sterigenics-us-llc-west-memphis-ar--fdaest-3002907620-2026-06-04) ## AT - [GE Healthcare Austria GmbH & Co OG (manufacturer, ZIPF Oberosterreich, AT): 21 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/ge-healthcare-austria-gmbh-and-co-og-zipf-oberosterreich-at--fdaest-8020021-2026-10-07) ## AU - [Daizo Eyewear PTY Ltd (manufacturer, Brighton Victoria, AU): 5 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)](/report/deviceestablishmentpulse/daizo-eyewear-pty-ltd-brighton-victoria-au--fdaest-3048653292-2026-07-19) - [EvERX PTY LTD (foreign exporter, Sydney New South Wales, AU): 5 new FDA device listings, incl. interventional fluoroscopic x-ray system](/report/deviceestablishmentpulse/everx-pty-ltd-sydney-new-south-wales-au--fdaest-3008496839-2026-08-24) - [Makar Consulting PTY Ltd (foreign exporter, Belrose New South Wales, AU): 21 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic](/report/deviceestablishmentpulse/makar-consulting-pty-ltd-belrose-new-south-wales-au--fdaest-3010703925-2026-10-16) - [Medical Resale PTY Limited (foreign exporter, Caloundra QLD Queensland, AU): 3 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/medical-resale-pty-limited-caloundra-qld-queensland-au--fdaest-3011416394-2026-08-26) - [Merit Medical Australia Pty Ltd. (foreign exporter, Braiside Victoria, AU): 6 new FDA device listings, incl. catheter, embolectomy](/report/deviceestablishmentpulse/merit-medical-australia-pty-ltd-braiside-victoria-au--fdaest-3033589330-2026-08-20) - [Omniscient Neurotechnology PTY Ltd (O8t) (manufacturer, Haymarket New South Wales, AU): 2 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/omniscient-neurotechnology-pty-ltd-o8t-haymarket-new-south-wales-au--fdaest-3017102960-2026-09-21) - [Signature Orthopaedics PTY Limited (manufacturer, Sydney New South Wales, AU): 12 new FDA device listings, incl. prosthesis, hip, femoral, resurfacing](/report/deviceestablishmentpulse/signature-orthopaedics-pty-limited-sydney-new-south-wales-au--fdaest-3008262872-2026-07-07) ## BB - [Imperial Trading Limited (foreign exporter, Bridgetown Saint Michael, BB): 9 new FDA device listings, incl. bag, urine collection, leg, for external use, sterile](/report/deviceestablishmentpulse/imperial-trading-limited-bridgetown-saint-michael-bb--fdaest-3000268902-2026-07-28) ## California - [15445361 Canada Inc. (foreign exporter, Shawinigan Quebec, CA): 25 new FDA device listings, incl. container, liquid medication, graduated](/report/deviceestablishmentpulse/15445361-canada-inc-shawinigan-quebec-ca--fdaest-3043051314-2026-09-13) - [Ads Dental System Inc. (repackager or relabeler, Ontario, CA): 7 new FDA device listings, incl. controller, foot, handpiece and cord](/report/deviceestablishmentpulse/ads-dental-system-inc-ontario-ca--fdaest-3015376465-2026-07-28) - [Advanced Imaging Services, Inc. (repackager or relabeler, Lathrop, CA): 7 new FDA device listings, incl. tomographic imager combining emission computed tomography with nuclear](/report/deviceestablishmentpulse/advanced-imaging-services-inc-lathrop-ca--fdaest-3012085143-2026-08-20) - [AG Marketing & Development Group Inc Dba Agmd Group (foreign exporter, Brampton Ontario, CA): 20 new FDA device listings, incl. tubes, vials, systems, serum separators, blood collection](/report/deviceestablishmentpulse/ag-marketing-and-development-group-inc-dba-agmd-group-brampton-ontario-ca--fdaest-3016844398-2026-08-25) - [Alcon Research, LLC (manufacturer, Irvine, CA): 2 new FDA device listings, incl. laser, ophthalmic](/report/deviceestablishmentpulse/alcon-research-llc-irvine-ca--fdaest-2028159-2026-08-20) - [Alcon Research, LLC (specification developer, Lake Forest, CA): 2 new FDA device listings, incl. laser, ophthalmic](/report/deviceestablishmentpulse/alcon-research-llc-lake-forest-ca--fdaest-3010208880-2026-08-20) - [Align Technology, Inc. (specification developer, San Jose, CA): 3 new FDA device listings, incl. light transmission caries detector](/report/deviceestablishmentpulse/align-technology-inc-san-jose-ca--fdaest-2953749-2026-09-30) - [Alom Technologies Corporation (contract manufacturer, Fremont, CA): 2 new FDA device listings, incl. dna specimen collection, saliva](/report/deviceestablishmentpulse/alom-technologies-corporation-fremont-ca--fdaest-3004597845-2026-09-23) - [Alphatec Spine, Inc. (manufacturer, Carlsbad, CA): 10 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/alphatec-spine-inc-carlsbad-ca--fdaest-2027467-2026-07-28) - [Amarigo Inc (manufacturer, Los Angeles, CA): 7 new FDA device listings, incl. pad, heating, powered](/report/deviceestablishmentpulse/amarigo-inc-los-angeles-ca--fdaest-3027135885-2026-09-24) - [AMD Medicom Inc. (manufacturer, Pointe-Claire, Montreal Quebec, CA): 9 new FDA device listings, incl. polymer patient examination glove](/report/deviceestablishmentpulse/amd-medicom-inc-pointe-claire-montreal-quebec-ca--fdaest-9611959-2026-10-15) - [Applied BioCode, Inc. (manufacturer, Santa Fe Springs, CA): 12 new FDA device listings, incl. instrumentation for clinical multiplex test systems](/report/deviceestablishmentpulse/applied-biocode-inc-santa-fe-springs-ca--fdaest-3007799234-2026-09-30) - [Ark Diagnostics Inc (manufacturer, Fremont, CA): 2 new FDA device listings, incl. anti-factor xa activity test system, apixaban](/report/deviceestablishmentpulse/ark-diagnostics-inc-fremont-ca--fdaest-3005755244-2026-09-11) - [Auris Health, Inc (manufacturer, Santa Clara, CA): 3 new FDA device listings, incl. integrated operating table-electromechanical surgical system](/report/deviceestablishmentpulse/auris-health-inc-santa-clara-ca--fdaest-3017425975-2026-08-27) - [Auris Health, Inc. (manufacturer, San Jose, CA): 2 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/auris-health-inc-san-jose-ca--fdaest-3023460764-2026-08-27) - [Autonomous Medical Devices Incorporated (manufacturer, Santa Ana, CA): 5 new FDA device listings, incl. assayed external control material for microbiology nucleic acid amplif](/report/deviceestablishmentpulse/autonomous-medical-devices-incorporated-santa-ana-ca--fdaest-3023999024-2026-06-16) - [Babylist, Inc. (repackager or relabeler, Emeryville, CA): 2 new FDA device listings, incl. pack, hot or cold, reusable](/report/deviceestablishmentpulse/babylist-inc-emeryville-ca--fdaest-3031827936-2026-08-18) - [Balt USA, LLC (manufacturer, Irvine, CA): 5 new FDA device listings, incl. catheter, percutaneous](/report/deviceestablishmentpulse/balt-usa-llc-irvine-ca--fdaest-3014162263-2026-09-28) - [Becton Dickinson Canada Inc. (foreign exporter, Mississauga Ontario, CA): 12 new FDA device listings, incl. computer, diagnostic, programmable](/report/deviceestablishmentpulse/becton-dickinson-canada-inc-mississauga-ontario-ca--fdaest-3045891669-2026-09-11) - [Beyes Dental Inc (manufacturer, Toronto Ontario, CA): 3 new FDA device listings, incl. gutta-percha](/report/deviceestablishmentpulse/beyes-dental-inc-toronto-ontario-ca--fdaest-3008770655-2026-09-16) - [Biocheck, Inc. (repackager or relabeler, Pleasant Hill, CA): 3 new FDA device listings, incl. helicobacter pylori](/report/deviceestablishmentpulse/biocheck-inc-pleasant-hill-ca--fdaest-2953756-2026-09-16) - [BioticsAI, Inc. (manufacturer, San Francisco, CA): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic](/report/deviceestablishmentpulse/bioticsai-inc-san-francisco-ca--fdaest-3047889344-2026-08-05) - [Boston Aesthetics Inc (other, Irvine, CA): 7 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/boston-aesthetics-inc-irvine-ca--fdaest-3036425107-2026-06-11) - [BTNX Inc. (repackager or relabeler, Pickering Ontario, CA): 11 new FDA device listings, incl. test, phencyclidine (pcp), over the counter](/report/deviceestablishmentpulse/btnx-inc-pickering-ontario-ca--fdaest-3003917514-2026-09-18) - [Can Technomed Trading Ltd. (foreign exporter, Richmond British Columbia, CA): 40 new FDA device listings, incl. system, tomography, computed, emission](/report/deviceestablishmentpulse/can-technomed-trading-ltd-richmond-british-columbia-ca--fdaest-3015276088-2026-10-15) - [Canadian Hospital Specialties Ltd. (contract manufacturer, OAKVILLE Ontario, CA): 12 new FDA device listings, incl. catheter, intravascular, therapeutic, long-term greater than 30 days](/report/deviceestablishmentpulse/canadian-hospital-specialties-ltd-oakville-ontario-ca--fdaest-8022210-2026-09-29) - [Carlsmed, Inc. (manufacturer, Carlsbad, CA): 2 new FDA device listings, incl. appliance, fixation, spinal intervertebral body](/report/deviceestablishmentpulse/carlsmed-inc-carlsbad-ca--fdaest-3017936978-2026-09-25) - [Cgbio USA, Inc. (repackager or relabeler, Irvine, CA): 47 new FDA device listings, incl. orthosis, spinal pedicle fixation](/report/deviceestablishmentpulse/cgbio-usa-inc-irvine-ca--fdaest-3039103971-2026-10-13) - [Clarity Design, Inc. (contract manufacturer, Poway, CA): 2 new FDA device listings, incl. marker, radiographic, implantable](/report/deviceestablishmentpulse/clarity-design-inc-poway-ca--fdaest-3011883032-2026-09-21) - [Conavi Medical Inc (specification developer, Toronto Ontario, CA): 3 new FDA device listings, incl. system, imaging, optical coherence tomography (oct)](/report/deviceestablishmentpulse/conavi-medical-inc-toronto-ontario-ca--fdaest-3012198618-2026-09-11) - [Cutera, Inc. (manufacturer, Brisbane, CA): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/cutera-inc-brisbane-ca--fdaest-2954354-2026-09-25) - [Dexcom, Inc. (specification developer, San Diego, CA): 5 new FDA device listings, incl. tape and bandage, adhesive](/report/deviceestablishmentpulse/dexcom-inc-san-diego-ca--fdaest-3004753838-2026-08-10) - [Diadent Group Intl., Inc. (foreign exporter, Vancouver British Columbia, CA): 6 new FDA device listings, incl. material, tooth shade, resin](/report/deviceestablishmentpulse/diadent-group-intl-inc-vancouver-british-columbia-ca--fdaest-9615399-2026-09-18) - [Diagnostic Automation/ Cortez Diagnostics Inc,. (manufacturer, Woodland Hills, CA): 6 new FDA device listings, incl. test for detection of microorganism(s) causing sexually transmitted in](/report/deviceestablishmentpulse/diagnostic-automation-cortez-diagnostics-inc-woodland-hills-ca--fdaest-2029372-2026-08-19) - [Diazyme Laboratories, Inc. (manufacturer, Poway, CA): 3 new FDA device listings, incl. lipoprotein, low-density, antigen, antiserum, control](/report/deviceestablishmentpulse/diazyme-laboratories-inc-poway-ca--fdaest-2032900-2026-08-11) - [Endologix LLC (specification developer, Santa Rosa, CA): 3 new FDA device listings, incl. peripheral mechanical thrombectomy with aspiration](/report/deviceestablishmentpulse/endologix-llc-santa-rosa-ca--fdaest-3008011247-2026-09-09) - [Endovascular Engineering, Inc. (manufacturer, Menlo Park, CA): 3 new FDA device listings, incl. thrombectomy whole blood return system](/report/deviceestablishmentpulse/endovascular-engineering-inc-menlo-park-ca--fdaest-3026567963-2026-10-14) - [Engineering Cpr Inc. (contract manufacturer, mississauga Ontario, CA): 11 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/engineering-cpr-inc-mississauga-ontario-ca--fdaest-3013485140-2026-07-23) - [Frontier Dental Supply Inc (foreign exporter, Aurora Ontario, CA): 12 new FDA device listings, incl. sealant, pit and fissure, and conditioner](/report/deviceestablishmentpulse/frontier-dental-supply-inc-aurora-ontario-ca--fdaest-3045891668-2026-05-11) - [Fusionx Medtech Inc. (repackager or relabeler, Whittier, CA): 22 new FDA device listings, incl. instrument, manual, surgical, general use](/report/deviceestablishmentpulse/fusionx-medtech-inc-whittier-ca--fdaest-3047889355-2026-07-28) - [Gravitas Medical, Inc. (manufacturer, Berkeley, CA): 2 new FDA device listings, incl. tubes, gastrointestinal (and accessories)](/report/deviceestablishmentpulse/gravitas-medical-inc-berkeley-ca--fdaest-3034881464-2026-08-21) - [Gurin Products LLC (repackager or relabeler, Tustin, CA): 2 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter](/report/deviceestablishmentpulse/gurin-products-llc-tustin-ca--fdaest-3006793151-2026-09-10) - [Happy Heart Care Services, LLC (repackager or relabeler, Menlo Park, CA): 2 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive](/report/deviceestablishmentpulse/happy-heart-care-services-llc-menlo-park-ca--fdaest-3049079140-2026-08-13) - [HydraFacial LLC (repackager or relabeler, Long Beach, CA): 5 new FDA device listings, incl. stimulator, muscle, powered](/report/deviceestablishmentpulse/hydrafacial-llc-long-beach-ca--fdaest-3016453096-2026-09-15) - [iCRco Inc. (repackager or relabeler, Goleta, CA): 5 new FDA device listings, incl. camera, multi format, radiological](/report/deviceestablishmentpulse/icrco-inc-goleta-ca--fdaest-3009717300-2026-07-22) - [Icu Medical, Inc. (specification developer, San Clemente, CA): 223 new FDA device listings, incl. tube, tracheostomy (w/wo connector)](/report/deviceestablishmentpulse/icu-medical-inc-san-clemente-ca--fdaest-2025816-2026-07-22) - [Innopex Limited (foreign exporter, Toronto Ontario, CA): 89 new FDA device listings, incl. dressing, wound, occlusive](/report/deviceestablishmentpulse/innopex-limited-toronto-ontario-ca--fdaest-3001124136-2026-10-15) - [Innovacyn, Inc. (manufacturer, Rialto, CA): 2 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/innovacyn-inc-rialto-ca--fdaest-3008750913-2026-09-16) - [Inova Diagnostics, Inc. (manufacturer, San Diego, CA): 3 new FDA device listings, incl. system, test, anticardiolipin immunological](/report/deviceestablishmentpulse/inova-diagnostics-inc-san-diego-ca--fdaest-2026994-2026-06-23) - [Inquis Medical, Inc. (manufacturer, Menlo Park, CA): 5 new FDA device listings, incl. aspiration thrombectomy catheter](/report/deviceestablishmentpulse/inquis-medical-inc-menlo-park-ca--fdaest-3031823122-2026-10-16) - [Integrity United Inc Dba Costcare (other, Anaheim, CA): 3 new FDA device listings, incl. mattress, air flotation, alternating pressure](/report/deviceestablishmentpulse/integrity-united-inc-dba-costcare-anaheim-ca--fdaest-3017375560-2026-09-08) - [Intuitive Surgical, Inc. (manufacturer, Santa Clara, CA): 9 new FDA device listings, incl. system, surgical, computer controlled instrument](/report/deviceestablishmentpulse/intuitive-surgical-inc-santa-clara-ca--fdaest-3015612252-2026-09-16) - [Intuitive Surgical, Inc. (manufacturer, Sunnyvale, CA): 9 new FDA device listings, incl. system, surgical, computer controlled instrument](/report/deviceestablishmentpulse/intuitive-surgical-inc-sunnyvale-ca--fdaest-3001675293-2026-09-16) - [Isomedix Operations, Inc (contract sterilizer, Ontario, CA): 7 new FDA device listings, incl. plate, fixation, bone](/report/deviceestablishmentpulse/isomedix-operations-inc-ontario-ca--fdaest-2032098-2026-10-15) - [Isomedix Operations, Inc. (contract sterilizer, Temecula, CA): 7 new FDA device listings, incl. percutaneous catheter, ultrasound](/report/deviceestablishmentpulse/isomedix-operations-inc-temecula-ca--fdaest-2030624-2026-10-14) - [Jmu Dental, Inc (repackager or relabeler, Fullerton, CA): 31 new FDA device listings, incl. agent, tooth bonding, resin](/report/deviceestablishmentpulse/jmu-dental-inc-fullerton-ca--fdaest-3014683120-2026-09-29) - [Karl Storz Endoscopy-America, Inc. (other, El Segundo, CA): 15 new FDA device listings, incl. endoscopic grasping/cutting instrument, non-powered](/report/deviceestablishmentpulse/karl-storz-endoscopy-america-inc-el-segundo-ca--fdaest-3010202439-2026-09-28) - [Kash Sales Inc. (foreign exporter, Richmond Hill Ontario, CA): 15 new FDA device listings, incl. agent, absorbable hemostatic, collagen based](/report/deviceestablishmentpulse/kash-sales-inc-richmond-hill-ontario-ca--fdaest-3003120666-2026-10-16) - [Leica Biosystems Imaging, Inc. (manufacturer, Vista, CA): 3 new FDA device listings, incl. whole slide imaging system](/report/deviceestablishmentpulse/leica-biosystems-imaging-inc-vista-ca--fdaest-3006791373-2026-09-15) - [Life Science Outsourcing, Inc. (contract sterilizer, Brea, CA): 15 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical](/report/deviceestablishmentpulse/life-science-outsourcing-inc-brea-ca--fdaest-2031093-2026-09-18) - [LifeSignals, Inc. (specification developer, Milpitas, CA): 4 new FDA device listings, incl. outpatient cardiac telemetry](/report/deviceestablishmentpulse/lifesignals-inc-milpitas-ca--fdaest-3010552191-2026-07-17) - [Lotfancy Inc (repackager or relabeler, Ontario, CA): 3 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/lotfancy-inc-ontario-ca--fdaest-3010395155-2026-08-20) - [Masimo Corporation (manufacturer, Irvine, CA): 4 new FDA device listings, incl. transmitters and receivers, electrocardiograph, telephone](/report/deviceestablishmentpulse/masimo-corporation-irvine-ca--fdaest-3011353843-2026-09-23) - [Medinova Group Co. (manufacturer, Laguna Beach, CA): 21 new FDA device listings, incl. shield, eye, ophthalmic (including sunlamp protective eyewear and post](/report/deviceestablishmentpulse/medinova-group-co-laguna-beach-ca--fdaest-3044466317-2026-05-09) - [Merit Medical Canada Ltd. (foreign exporter, Markham Ontario, CA): 6 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization](/report/deviceestablishmentpulse/merit-medical-canada-ltd-markham-ontario-ca--fdaest-3012536737-2026-08-20) - [Neptune Medical, Inc (manufacturer, Burlingame, CA): 3 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology](/report/deviceestablishmentpulse/neptune-medical-inc-burlingame-ca--fdaest-3015451828-2026-09-16) - [Neurofield, Inc. (specification developer, Santa Barbara, CA): 3 new FDA device listings, incl. cranial electrotherapy stimulator to treat insomnia and/or anxiety](/report/deviceestablishmentpulse/neurofield-inc-santa-barbara-ca--fdaest-3010900508-2026-05-05) - [Nihon Kohden America, Inc. (manufacturer, Irvine, CA): 5 new FDA device listings, incl. tape and bandage, adhesive](/report/deviceestablishmentpulse/nihon-kohden-america-inc-irvine-ca--fdaest-2080783-2026-08-06) - [Nucare LLC (specification developer, Montclair, CA): 4 new FDA device listings, incl. latex patient examination glove](/report/deviceestablishmentpulse/nucare-llc-montclair-ca--fdaest-3042367543-2026-07-28) - [Optik K & R Inc. (contract manufacturer, Toronto Ontario, CA): 2 new FDA device listings, incl. lens, contact (other material) - daily](/report/deviceestablishmentpulse/optik-k-and-r-inc-toronto-ontario-ca--fdaest-3004145084-2026-10-15) - [OrthAlign, Inc. (manufacturer, Irvine, CA): 3 new FDA device listings, incl. intraoperative orthopedic joint assessment aid](/report/deviceestablishmentpulse/orthalign-inc-irvine-ca--fdaest-3007521480-2026-08-20) - [Pac-Dent Inc. (manufacturer, Brea, CA): 2 new FDA device listings, incl. system, optical impression, computer assisted design and manufacturing](/report/deviceestablishmentpulse/pac-dent-inc-brea-ca--fdaest-2086043-2026-08-19) - [Paragon Implant Mfg., LLC (manufacturer, Calabasas, CA): 2 new FDA device listings, incl. abutment, implant, dental, endosseous](/report/deviceestablishmentpulse/paragon-implant-mfg-llc-calabasas-ca--fdaest-3005409899-2026-09-18) - [Patterson Dental Canada Inc. (repackager or relabeler, Montreal Quebec, CA): 4 new FDA device listings, incl. device, caries detection](/report/deviceestablishmentpulse/patterson-dental-canada-inc-montreal-quebec-ca--fdaest-3000219976-2026-08-04) - [Primed Medical Products Inc. (specification developer, Edmonton Alberta, CA): 2 new FDA device listings, incl. medical gowns with chemotherapy labeling claims - tested for use with](/report/deviceestablishmentpulse/primed-medical-products-inc-edmonton-alberta-ca--fdaest-9615270-2026-09-21) - [Prism Pacific Industries LLC (repackager or relabeler, Sacramento, CA): 2 new FDA device listings, incl. protector, skin pressure](/report/deviceestablishmentpulse/prism-pacific-industries-llc-sacramento-ca--fdaest-3026523692-2026-08-20) - [Prismatik Dentalcraft, Inc. (manufacturer, Irvine, CA): 2 new FDA device listings, incl. resin, denture, relining, repairing, rebasing](/report/deviceestablishmentpulse/prismatik-dentalcraft-inc-irvine-ca--fdaest-3011649314-2026-09-10) - [PROCEPT BioRobotics Corporation (manufacturer, San Jose, CA): 4 new FDA device listings, incl. fluid jet removal system](/report/deviceestablishmentpulse/procept-biorobotics-corporation-san-jose-ca--fdaest-3027788423-2026-09-25) - [Proguard Health Inc. (contract manufacturer, Los Angeles, CA): 5 new FDA device listings, incl. handpiece, air-powered, dental](/report/deviceestablishmentpulse/proguard-health-inc-los-angeles-ca--fdaest-3016710511-2026-06-23) - [Providence Medical Technology, Inc. (manufacturer, Pleasanton, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/providence-medical-technology-inc-pleasanton-ca--fdaest-3009394448-2026-10-05) - [Ray Vision Inc. (specification developer, Lake Forest, CA): 18 new FDA device listings, incl. retinoscope, ac-powered](/report/deviceestablishmentpulse/ray-vision-inc-lake-forest-ca--fdaest-3013436538-2026-05-27) - [Resmed Corp (manufacturer, San Diego, CA): 9 new FDA device listings, incl. accessory to continuous ventilator (respirator)](/report/deviceestablishmentpulse/resmed-corp-san-diego-ca--fdaest-3007573469-2026-09-30) - [Roche Molecular Systems, Inc. (specification developer, Pleasanton, CA): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system](/report/deviceestablishmentpulse/roche-molecular-systems-inc-pleasanton-ca--fdaest-3004141078-2026-09-10) - [Serpex Medical, Inc. (specification developer, Santa Clara, CA): 2 new FDA device listings, incl. unit, cryosurgical, accessories](/report/deviceestablishmentpulse/serpex-medical-inc-santa-clara-ca--fdaest-3026787544-2026-10-12) - [Shenb America, Inc. (other, Brea, CA): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/shenb-america-inc-brea-ca--fdaest-3045535064-2026-08-21) - [Si-Bone, Inc. (manufacturer, Santa Clara, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/si-bone-inc-santa-clara-ca--fdaest-3021948057-2026-09-28) - [Si-Bone, Inc. (other, Santa Clara, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/si-bone-inc-santa-clara-ca--fdaest-3007700286-2026-09-28) - [Siemens Healthcare Limited (foreign exporter, Oakville Ontario, CA): 3 new FDA device listings, incl. digital breast tomosynthesis](/report/deviceestablishmentpulse/siemens-healthcare-limited-oakville-ontario-ca--fdaest-3012127758-2026-07-28) - [Sight Sciences, Inc. (specification developer, Menlo Park, CA): 3 new FDA device listings, incl. pump, infusion, ophthalmic](/report/deviceestablishmentpulse/sight-sciences-inc-menlo-park-ca--fdaest-3010363671-2026-08-24) - [Skyward Medical Devices LLC (repackager or relabeler, Eastvale, CA): 28 new FDA device listings, incl. shield, protective, personnel](/report/deviceestablishmentpulse/skyward-medical-devices-llc-eastvale-ca--fdaest-3043009869-2026-08-03) - [Spectrum Assembly Inc. (contract manufacturer, Carlsbad, CA): 5 new FDA device listings, incl. stimulator, spinal-cord, implanted (pain relief)](/report/deviceestablishmentpulse/spectrum-assembly-inc-carlsbad-ca--fdaest-3002672225-2026-09-08) - [Spinal Elements, Inc. (manufacturer, Carlsbad, CA): 3 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/spinal-elements-inc-carlsbad-ca--fdaest-3004893332-2026-07-21) - [Sterigenics Radiation Technologies Canada, Inc (contract sterilizer, PORT COQUITLAM British Columbia, CA): 7 new FDA device listings, incl. table, operating-room, electrical](/report/deviceestablishmentpulse/sterigenics-radiation-technologies-canada-inc-port-coquitlam-british-columbi-ca--fdaest-9680579-2026-07-06) - [Sterigenics Radiation Technologies, LLC (contract sterilizer, San Diego, CA): 6 new FDA device listings, incl. glucose range monitoring system](/report/deviceestablishmentpulse/sterigenics-radiation-technologies-llc-san-diego-ca--fdaest-2024024-2026-07-07) - [Sterigenics U.S. LLC (contract sterilizer, Hayward, CA): 6 new FDA device listings, incl. system, facet screw spinal device](/report/deviceestablishmentpulse/sterigenics-u-s-llc-hayward-ca--fdaest-2953359-2026-05-07) - [Sterigenics U.S., LLC (contract sterilizer, Ontario, CA): 7 new FDA device listings, incl. integrated continuous glucose monitoring system, factory calibrated](/report/deviceestablishmentpulse/sterigenics-u-s-llc-ontario-ca--fdaest-2029015-2026-08-12) - [Sterigenics U.S., LLC (contract sterilizer, Tustin, CA): 7 new FDA device listings, incl. injector and syringe, angiographic](/report/deviceestablishmentpulse/sterigenics-u-s-llc-tustin-ca--fdaest-2022435-2026-07-06) - [Sterigenics US LLC (contract sterilizer, Los Angeles, CA): 8 new FDA device listings, incl. device, surgical, cryogenic](/report/deviceestablishmentpulse/sterigenics-us-llc-los-angeles-ca--fdaest-2011171-2026-09-30) - [SW Technologies Inc. (manufacturer, Union City, CA): 4 new FDA device listings, incl. polymer patient examination glove](/report/deviceestablishmentpulse/sw-technologies-inc-union-city-ca--fdaest-2939388-2026-08-26) - [Tandem Diabetes Care, Inc. (manufacturer, San Diego, CA): 3 new FDA device listings, incl. interoperable automated glycemic controller](/report/deviceestablishmentpulse/tandem-diabetes-care-inc-san-diego-ca--fdaest-3007981285-2026-08-03) - [Tecan Cdmo Solutions Mh, Corp. (contract manufacturer, Morgan Hill, CA): 3 new FDA device listings, incl. deformability cytometry for sepsis risk assessment](/report/deviceestablishmentpulse/tecan-cdmo-solutions-mh-corp-morgan-hill-ca--fdaest-3003537036-2026-07-13) - [Terumo Medical Canada, Inc. (foreign exporter, Vaughan Ontario, CA): 4 new FDA device listings, incl. prosthesis, vascular graft, of 6mm and greater diameter](/report/deviceestablishmentpulse/terumo-medical-canada-inc-vaughan-ontario-ca--fdaest-3008307705-2026-07-30) - [The Binding Site, Inc. (manufacturer, San Diego, CA): 6 new FDA device listings, incl. lambda, antigen, antiserum, control](/report/deviceestablishmentpulse/the-binding-site-inc-san-diego-ca--fdaest-2083566-2026-05-12) - [Tpc Advanced Technology, Inc. (repackager or relabeler, City Industry, CA): 4 new FDA device listings, incl. scanner, color](/report/deviceestablishmentpulse/tpc-advanced-technology-inc-city-industry-ca--fdaest-2031508-2026-09-28) - [Traferox Technologies Inc. (manufacturer, Mississauga Ontario, CA): 3 new FDA device listings, incl. system, perfusion, kidney](/report/deviceestablishmentpulse/traferox-technologies-inc-mississauga-ontario-ca--fdaest-3027669473-2026-09-21) - [Trelleborg Sealing Solutions Us, Inc. (contract manufacturer, Paso Robles, CA): 3 new FDA device listings, incl. implant, eye valve](/report/deviceestablishmentpulse/trelleborg-sealing-solutions-us-inc-paso-robles-ca--fdaest-3013674629-2026-06-17) - [Trimed, Inc. (manufacturer, Santa Clarita, CA): 4 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/trimed-inc-santa-clarita-ca--fdaest-2031009-2026-08-13) - [Universal Brain Inc. (specification developer, Palo Alto, CA): 3 new FDA device listings, incl. stimulator, auditory, evoked response](/report/deviceestablishmentpulse/universal-brain-inc-palo-alto-ca--fdaest-3038896098-2026-09-19) - [UPS Supply Chain Solutions, Inc. (repackager or relabeler, Mira Loma, CA): 4 new FDA device listings, incl. enzyme linked immunoabsorbent assay, rubeola igg](/report/deviceestablishmentpulse/ups-supply-chain-solutions-inc-mira-loma-ca--fdaest-3009637528-2026-07-29) - [Valencia Technologies Corporation (manufacturer, Valencia, CA): 4 new FDA device listings, incl. stimulator, tibial, electrical, implantable, for urinary incontinence](/report/deviceestablishmentpulse/valencia-technologies-corporation-valencia-ca--fdaest-3010878085-2026-05-01) - [Venus Concept Inc. (manufacturer, San Jose, CA): 7 new FDA device listings, incl. powered light based non-laser surgical instrument with thermal effect](/report/deviceestablishmentpulse/venus-concept-inc-san-jose-ca--fdaest-3006515340-2026-07-06) - [Victorch Meditek, Inc. (manufacturer, San Diego, CA): 15 new FDA device listings, incl. applicator, absorbent tipped, sterile](/report/deviceestablishmentpulse/victorch-meditek-inc-san-diego-ca--fdaest-2032364-2026-07-02) - [W&H Impex Inc. (foreign exporter, Windsor Ontario, CA): 8 new FDA device listings, incl. sterilizer, steam](/report/deviceestablishmentpulse/w-and-h-impex-inc-windsor-ontario-ca--fdaest-3007279848-2026-09-25) - [Zyris, Inc. (manufacturer, Santa Barbara, CA): 3 new FDA device listings, incl. drape, surgical, exempt](/report/deviceestablishmentpulse/zyris-inc-santa-barbara-ca--fdaest-2032574-2026-06-17) ## CN - [Aena Medical (Jiangsu) Co.,Ltd. (contract manufacturer, Jiangyin City Jiangsu, CN): 3 new FDA device listings, incl. needle, hypodermic, single lumen](/report/deviceestablishmentpulse/aena-medical-jiangsu-co-ltd-jiangyin-city-jiangsu-cn--fdaest-3031915926-2026-09-01) - [Allmed Industrial Limited (manufacturer, Shenzhen City Guangdong, CN): 5 new FDA device listings, incl. polymer patient examination glove](/report/deviceestablishmentpulse/allmed-industrial-limited-shenzhen-city-guangdong-cn--fdaest-3011089435-2026-06-04) - [Allmed Medical Products Co., Ltd. (contract manufacturer, Zhijiang City Hubei, CN): 5 new FDA device listings, incl. vinyl patient examination glove](/report/deviceestablishmentpulse/allmed-medical-products-co-ltd-zhijiang-city-hubei-cn--fdaest-3011862887-2026-06-04) - [Allwin First Aid Supplies Taizhou Co., Ltd (manufacturer, Taizhou Jiangsu, CN): 3 new FDA device listings, incl. vinyl patient examination glove](/report/deviceestablishmentpulse/allwin-first-aid-supplies-taizhou-co-ltd-taizhou-jiangsu-cn--fdaest-3045078803-2026-08-30) - [Alton Shanghai Medical Instruments Co Ltd (manufacturer, Shanghai, CN): 3 new FDA device listings, incl. device, measuring, for panendoscope](/report/deviceestablishmentpulse/alton-shanghai-medical-instruments-co-ltd-shanghai-cn--fdaest-3008797804-2026-06-05) - [Amphenol Medical Technologies (Dongguan) Co., Ltd. (contract manufacturer, Dongguan Guangdong, CN): 2 new FDA device listings, incl. computer, diagnostic, programmable](/report/deviceestablishmentpulse/amphenol-medical-technologies-dongguan-co-ltd-dongguan-guangdong-cn--fdaest-3013596024-2026-08-17) - [Andon Medical co., LTD (contract manufacturer, Tianjin, CN): 2 new FDA device listings, incl. multi-analyte respiratory virus antigen detection test](/report/deviceestablishmentpulse/andon-medical-co-ltd-tianjin-cn--fdaest-3008573045-2026-09-16) - [Anhui Kangfu Industrial Foreign Trade Co.,Ltd (manufacturer, Tianchang Anhui, CN): 5 new FDA device listings, incl. helmet, cranial, for protective use](/report/deviceestablishmentpulse/anhui-kangfu-industrial-foreign-trade-co-ltd-tianchang-anhui-cn--fdaest-3010595009-2026-09-08) - [Anqing Clean Dental Instrument Technology Co.,Ltd (manufacturer, Anqing City Anhui, CN): 47 new FDA device listings, incl. cotton, roll](/report/deviceestablishmentpulse/anqing-clean-dental-instrument-technology-co-ltd-anqing-city-anhui-cn--fdaest-3038191347-2026-07-21) - [Assure Tech. (Hangzhou) Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. sperm, antigen, antiserum, control](/report/deviceestablishmentpulse/assure-tech-hangzhou-co-ltd-hangzhou-zhejiang-cn--fdaest-3038560224-2026-07-27) - [Assure Tech. (Hangzhou) Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. sperm, antigen, antiserum, control](/report/deviceestablishmentpulse/assure-tech-hangzhou-co-ltd-hangzhou-zhejiang-cn--fdaest-3009585529-2026-07-27) - [Beijing Infervision Healthcare Medical Technology Co., Ltd. (manufacturer, Beijing, CN): 3 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/beijing-infervision-healthcare-medical-technology-co-ltd-beijing-cn--fdaest-3017489096-2026-07-22) - [Beijing Konted Medical Technology Co., Ltd (manufacturer, Beijing, CN): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic](/report/deviceestablishmentpulse/beijing-konted-medical-technology-co-ltd-beijing-cn--fdaest-3027501622-2026-07-27) - [Beijing Nubway S&T Co.,Ltd. (manufacturer, Beijing, CN): 4 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/beijing-nubway-s-and-t-co-ltd-beijing-cn--fdaest-3017124433-2026-09-21) - [Beijing Sanhe Laser Co., Ltd. (foreign exporter, Beijing, CN): 6 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/beijing-sanhe-laser-co-ltd-beijing-cn--fdaest-3048246437-2026-06-11) - [Beijing Spiritlaser Science & Technology Co., Ltd. (manufacturer, Beijing, CN): 3 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/beijing-spiritlaser-science-and-technology-co-ltd-beijing-cn--fdaest-3017132875-2026-08-09) - [Beijing Winkonlaser Technology Limited (manufacturer, Beijing, CN): 5 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning](/report/deviceestablishmentpulse/beijing-winkonlaser-technology-limited-beijing-cn--fdaest-3015452693-2026-08-18) - [Bestreat Safety & First Aid Solution Co., Ltd (foreign exporter, Wuhan Hubei, CN): 3 new FDA device listings, incl. multiple use blood lancet for single patient use only](/report/deviceestablishmentpulse/bestreat-safety-and-first-aid-solution-co-ltd-wuhan-hubei-cn--fdaest-3025413691-2026-08-13) - [Bioteke Corporation (Wuxi) Co., Ltd (manufacturer, Wuxi City Jiangsu, CN): 10 new FDA device listings, incl. test, opiates, over the counter](/report/deviceestablishmentpulse/bioteke-corporation-wuxi-co-ltd-wuxi-city-jiangsu-cn--fdaest-3016837106-2026-09-17) - [Boen Healthcare Co., Ltd. (specification developer, Suzhou Jiangsu, CN): 125 new FDA device listings, incl. apparatus, suction, operating-room, wall vacuum powered](/report/deviceestablishmentpulse/boen-healthcare-co-ltd-suzhou-jiangsu-cn--fdaest-3045058049-2026-09-01) - [Canyon Medical Inc. (manufacturer, Nanjing Jiangsu, CN): 2 new FDA device listings, incl. catheter, nephrostomy, general & plastic surgery](/report/deviceestablishmentpulse/canyon-medical-inc-nanjing-jiangsu-cn--fdaest-3016688836-2026-09-23) - [Carestream Healthcare International Company, Ltd (contract manufacturer, Shanghai, CN): 4 new FDA device listings, incl. generator, high-voltage, x-ray, diagnostic](/report/deviceestablishmentpulse/carestream-healthcare-international-company-ltd-shanghai-cn--fdaest-3004105475-2026-06-05) - [Changshu Rozer Sterilization Technology Co., Ltd. (contract sterilizer, Changshu Jiangsu, CN): 2 new FDA device listings, incl. evacuator, bladder, manually operated](/report/deviceestablishmentpulse/changshu-rozer-sterilization-technology-co-ltd-changshu-jiangsu-cn--fdaest-3011707784-2026-09-01) - [Changzhou Atomic Hi-Tech Radiation Co., Ltd. (contract sterilizer, CHANGZHOU Jiangsu, CN): 3 new FDA device listings, incl. anti fog solution and accessories, endoscopy](/report/deviceestablishmentpulse/changzhou-atomic-hi-tech-radiation-co-ltd-changzhou-jiangsu-cn--fdaest-3006636956-2026-05-28) - [Changzhou Biomet Medical Devices Co., Ltd. (contract manufacturer, Changzhou City Jiangsu, CN): 8 new FDA device listings, incl. plate, bone](/report/deviceestablishmentpulse/changzhou-biomet-medical-devices-co-ltd-changzhou-city-jiangsu-cn--fdaest-3007923096-2026-09-21) - [Changzhou Newmed Micro-Medtech Co., Ltd. (manufacturer, Changzhou City Jiangsu, CN): 3 new FDA device listings, incl. accessories, catheter](/report/deviceestablishmentpulse/changzhou-newmed-micro-medtech-co-ltd-changzhou-city-jiangsu-cn--fdaest-3043141270-2026-07-23) - [Chengdu Cryo-Push Medical Technology Co.,Ltd (manufacturer, CHENGDU Sichuan, CN): 4 new FDA device listings, incl. pack, hot or cold, reusable](/report/deviceestablishmentpulse/chengdu-cryo-push-medical-technology-co-ltd-chengdu-sichuan-cn--fdaest-3011491271-2026-05-12) - [CHISON Medical Technologies Co., Ltd. (manufacturer, WUXI Jiangsu, CN): 3 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic](/report/deviceestablishmentpulse/chison-medical-technologies-co-ltd-wuxi-jiangsu-cn--fdaest-3004753388-2026-05-24) - [Conod Medical Co.,Limited (contract manufacturer, Changshu Jiangsu, CN): 2 new FDA device listings, incl. irrigation kit (wounds)](/report/deviceestablishmentpulse/conod-medical-co-limited-changshu-jiangsu-cn--fdaest-3006673317-2026-09-16) - [Conod Medical Shuyang Co., Ltd. (contract manufacturer, Shuyang Jiangsu, CN): 3 new FDA device listings, incl. adaptor, ureteral catheter](/report/deviceestablishmentpulse/conod-medical-shuyang-co-ltd-shuyang-jiangsu-cn--fdaest-3016171914-2026-09-22) - [Deepintec Scientific Co., Ltd (manufacturer, Beijing, CN): 6 new FDA device listings, incl. wire, guide, catheter](/report/deviceestablishmentpulse/deepintec-scientific-co-ltd-beijing-cn--fdaest-3026317086-2026-05-27) - [Denjoy Dental Co., Ltd (manufacturer, Changsha city Hunan, CN): 2 new FDA device listings, incl. endodontic kit](/report/deviceestablishmentpulse/denjoy-dental-co-ltd-changsha-city-hunan-cn--fdaest-3008590661-2026-09-06) - [Dentalmaster (Xiamen) Medical Technology Co., Ltd. (manufacturer, Xiamen Fujian, CN): 25 new FDA device listings, incl. explorer, operative](/report/deviceestablishmentpulse/dentalmaster-xiamen-medical-technology-co-ltd-xiamen-fujian-cn--fdaest-3049848767-2026-09-18) - [Depuy Synthes (Suzhou) Medical Devices Co., Ltd. (manufacturer, SUZHOU Jiangsu, CN): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol](/report/deviceestablishmentpulse/depuy-synthes-suzhou-medical-devices-co-ltd-suzhou-jiangsu-cn--fdaest-3006356043-2026-09-24) - [Devon Medical Products (Jiangsu) Ltd (repackager or relabeler, Nantong Jiangsu, CN): 3 new FDA device listings, incl. stocking, medical support (for general medical purposes)](/report/deviceestablishmentpulse/devon-medical-products-jiangsu-ltd-nantong-jiangsu-cn--fdaest-3009538657-2026-07-15) - [Dikaku Industrial Co.,Limited (manufacturer, Hong Kong, CN): 3 new FDA device listings, incl. pack, hot or cold, reusable](/report/deviceestablishmentpulse/dikaku-industrial-co-limited-hong-kong-cn--fdaest-3023876581-2026-09-18) - [Dong Guan Jia Shuan Industrial Co., Ltd (manufacturer, Dongguan Guangdong, CN): 5 new FDA device listings, incl. cushion, flotation](/report/deviceestablishmentpulse/dong-guan-jia-shuan-industrial-co-ltd-dongguan-guangdong-cn--fdaest-3045925755-2026-07-24) - [Dongguan Bao Kang Dian Zi Ke Ji Limited (contract manufacturer, Dongguan City Guangdong, CN): 3 new FDA device listings, incl. arthroscope](/report/deviceestablishmentpulse/dongguan-bao-kang-dian-zi-ke-ji-limited-dongguan-city-guangdong-cn--fdaest-3020978007-2026-05-12) - [Dongguan Lee-Mat Sports Technology Co., Ltd (manufacturer, Dongguan Guangdong, CN): 4 new FDA device listings, incl. orthosis, limb brace](/report/deviceestablishmentpulse/dongguan-lee-mat-sports-technology-co-ltd-dongguan-guangdong-cn--fdaest-3023212654-2026-05-31) - [Dongguan Letme Medical Technology Co., Ltd. (manufacturer, Dongguan Guangdong, CN): 3 new FDA device listings, incl. light based over-the-counter hair removal](/report/deviceestablishmentpulse/dongguan-letme-medical-technology-co-ltd-dongguan-guangdong-cn--fdaest-3048248141-2026-06-11) - [Dongguan Miqiang Technology Co., Ltd (contract manufacturer, Dongguan Guangdong, CN): 4 new FDA device listings, incl. accessory, surgical apparel](/report/deviceestablishmentpulse/dongguan-miqiang-technology-co-ltd-dongguan-guangdong-cn--fdaest-3019887520-2026-08-10) - [Dongguan Paidaxing Technology Co., Ltd (manufacturer, Dongguan City Guangdong, CN): 3 new FDA device listings, incl. massager, therapeutic, electric](/report/deviceestablishmentpulse/dongguan-paidaxing-technology-co-ltd-dongguan-city-guangdong-cn--fdaest-3046007041-2026-06-30) - [Dongguan Quanding Medical Supplies Co., Ltd (manufacturer, Dongguan Guangdong, CN): 7 new FDA device listings, incl. unit, heating, powered](/report/deviceestablishmentpulse/dongguan-quanding-medical-supplies-co-ltd-dongguan-guangdong-cn--fdaest-3017450375-2026-05-16) - [Dongyang City Yonoel Outdoor Products Co.,Ltd (contract manufacturer, Dongyang Zhejiang, CN): 2 new FDA device listings, incl. mouthpiece, breathing](/report/deviceestablishmentpulse/dongyang-city-yonoel-outdoor-products-co-ltd-dongyang-zhejiang-cn--fdaest-3021282544-2026-08-31) - [Edan Instruments, Inc. (contract manufacturer, Shenzhen Guangdong, CN): 13 new FDA device listings, incl. monitor, physiological, patient(with arrhythmia detection or alarms)](/report/deviceestablishmentpulse/edan-instruments-inc-shenzhen-guangdong-cn--fdaest-3003971136-2026-08-11) - [Eternal (Shanghai) Medical Technology Co., Ltd. (contract sterilizer, Shanghai, CN): 2 new FDA device listings, incl. dislodger, stone, flexible](/report/deviceestablishmentpulse/eternal-shanghai-medical-technology-co-ltd-shanghai-cn--fdaest-3038296436-2026-09-18) - [Exceldent Dental Technology Development Co., Ltd. (contract manufacturer, Zhuhai Guangdong, CN): 2 new FDA device listings, incl. bracket, plastic, orthodontic](/report/deviceestablishmentpulse/exceldent-dental-technology-development-co-ltd-zhuhai-guangdong-cn--fdaest-3015456817-2026-09-19) - [Ezisurg Medical Co., Ltd. (manufacturer, Shanghai, CN): 2 new FDA device listings, incl. staple, implantable](/report/deviceestablishmentpulse/ezisurg-medical-co-ltd-shanghai-cn--fdaest-3014264910-2026-09-29) - [Fesun Shanghai Co., Ltd. (manufacturer, shanghai, CN): 7 new FDA device listings, incl. tape and bandage, adhesive](/report/deviceestablishmentpulse/fesun-shanghai-co-ltd-shanghai-cn--fdaest-3017896419-2026-05-12) - [Flexicare Medical (Dongguan) Ltd. (contract manufacturer, DONGGUAN CITY Guangdong, CN): 2 new FDA device listings, incl. bronchoscope (flexible or rigid)](/report/deviceestablishmentpulse/flexicare-medical-dongguan-ltd-dongguan-city-guangdong-cn--fdaest-3006061749-2026-09-04) - [Fofo Medical Co.,Ltd (foreign exporter, Xiamen Fujian, CN): 20 new FDA device listings, incl. exerciser, finger, powered](/report/deviceestablishmentpulse/fofo-medical-co-ltd-xiamen-fujian-cn--fdaest-3045077467-2026-07-24) - [Foshan Fricheer Medical Technology Co.,Ltd (manufacturer, Foshan City Guangdong, CN): 7 new FDA device listings, incl. adaptor, hygiene](/report/deviceestablishmentpulse/foshan-fricheer-medical-technology-co-ltd-foshan-city-guangdong-cn--fdaest-3030226293-2026-05-20) - [Foshan Haiseer Electronic Technology Co., Ltd. (manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. bandage, elastic](/report/deviceestablishmentpulse/foshan-haiseer-electronic-technology-co-ltd-foshan-guangdong-cn--fdaest-3043729119-2026-07-17) - [Foshan Hongfeng Co.,Ltd (contract manufacturer, Foshan Guangdong, CN): 2 new FDA device listings, incl. sleeve, limb, compressible](/report/deviceestablishmentpulse/foshan-hongfeng-co-ltd-foshan-guangdong-cn--fdaest-3013440654-2026-09-15) - [Foshan Pingchuang Medical Technology Co., Ltd (manufacturer, Foshan City Guangdong, CN): 4 new FDA device listings, incl. media, coupling, ultrasound](/report/deviceestablishmentpulse/foshan-pingchuang-medical-technology-co-ltd-foshan-city-guangdong-cn--fdaest-3014317667-2026-07-15) - [Foshan Shiding Technology Co., Ltd. (contract manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. stimulator, transcutaneous electrical, aesthetic purposes](/report/deviceestablishmentpulse/foshan-shiding-technology-co-ltd-foshan-guangdong-cn--fdaest-3018259873-2026-09-03) - [Foshan Soco Precision Instrument Co.,Ltd. (manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. loupe, diagnostic/surgical](/report/deviceestablishmentpulse/foshan-soco-precision-instrument-co-ltd-foshan-guangdong-cn--fdaest-3009391651-2026-10-16) - [Foshan Topmed Dental Co., Ltd. (manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. handpiece, air-powered, dental](/report/deviceestablishmentpulse/foshan-topmed-dental-co-ltd-foshan-guangdong-cn--fdaest-3018197668-2026-05-28) - [Fujian Unisoft Hygiene Products Co.,Ltd (manufacturer, Quanzhou Fujian, CN): 3 new FDA device listings, incl. garment, protective, for incontinence](/report/deviceestablishmentpulse/fujian-unisoft-hygiene-products-co-ltd-quanzhou-fujian-cn--fdaest-3045924479-2026-05-05) - [Gauke (Hubei) Healthcare Co., Ltd (foreign exporter, Huanggang City Hubei, CN): 4 new FDA device listings, incl. polymer patient examination glove](/report/deviceestablishmentpulse/gauke-hubei-healthcare-co-ltd-huanggang-city-hubei-cn--fdaest-3034605486-2026-08-24) - [Gauke International Trading Co., Ltd. (foreign exporter, Wuhan Hubei, CN): 5 new FDA device listings, incl. mask, surgical](/report/deviceestablishmentpulse/gauke-international-trading-co-ltd-wuhan-hubei-cn--fdaest-3026263452-2026-08-24) - [Gcmedica Enterprise Ltd.(Wuxi) (manufacturer, WUXI Jiangsu, CN): 3 new FDA device listings, incl. applicator, vaginal](/report/deviceestablishmentpulse/gcmedica-enterprise-ltd-wuxi-wuxi-jiangsu-cn--fdaest-3018503755-2026-09-04) 1 [2](/hub/deviceestablishmentpulse/records/2) [3](/hub/deviceestablishmentpulse/records/3) [4](/hub/deviceestablishmentpulse/records/4) [5](/hub/deviceestablishmentpulse/records/5) [Browse DeviceEstablishmentPulse by category and location](/hub/deviceestablishmentpulse) · [Search and filter DeviceEstablishmentPulse](/v/deviceestablishmentpulse)