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).

AE

• Nas Med LLC Fz (foreign exporter, DUBAI Dubayy, AE): 7 new FDA device listings, incl. staple, implantable

Alabama

• Advanced Product Solutions Inc. (contract manufacturer, Dothan, AL): 3 new FDA device listings, incl. instrument, surgical, disposable
• Curiteva, Inc. (contract manufacturer, Tanner, AL): 11 new FDA device listings, incl. orthopedic stereotaxic instrument
• Dunamis Medical LLC (manufacturer, Greenville, AL): 3 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene
• Elite Medical, LLC (contract manufacturer, Florence, AL): 17 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Rohrer Aesthetics, Inc. (other, Homewood, AL): 3 new FDA device listings, incl. powered laser surgical instrument
• Turner Medical Inc. (contract manufacturer, Athens, AL): 9 new FDA device listings, incl. plate, fixation, bone

Arizona

• Aesthetic Protools, Inc. (specification developer, Scottsdale, AZ): 3 new FDA device listings, incl. powered light based non-laser surgical instrument with thermal effect
• Aurora Gp Lab Inc (contract manufacturer, Goodyear, AZ): 6 new FDA device listings, incl. lens, contact, orthokeratology, overnight
• Bard Peripheral Vascular, Inc. (contract manufacturer, Tempe, AZ): 2 new FDA device listings, incl. shunt, portosystemic, endoprosthesis
• Dexcom, Inc. (manufacturer, Mesa, AZ): 3 new FDA device listings, incl. integrated continuous glucose monitor for non-intensive glucose manage
• Dexcom, Inc. (manufacturer, Mesa, AZ): 5 new FDA device listings, incl. tape and bandage, adhesive
• Ge Parallel Design, Inc. (manufacturer, Phoenix, AZ): 19 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Sequitur Health Corp. (manufacturer, Phoenix, AZ): 3 new FDA device listings, incl. analyzer, chemistry (photometric, discrete), for clinical use

Arkansas

• Sterigenics US LLC (contract sterilizer, West Memphis, AR): 4 new FDA device listings, incl. insufflator, laparoscopic

AT

• GE Healthcare Austria GmbH & Co OG (manufacturer, ZIPF Oberosterreich, AT): 21 new FDA device listings, incl. transducer, ultrasonic, diagnostic

AU

• Daizo Eyewear PTY Ltd (manufacturer, Brighton Victoria, AU): 5 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• EvERX PTY LTD (foreign exporter, Sydney New South Wales, AU): 5 new FDA device listings, incl. interventional fluoroscopic x-ray system
• Makar Consulting PTY Ltd (foreign exporter, Belrose New South Wales, AU): 21 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic
• Medical Resale PTY Limited (foreign exporter, Caloundra QLD Queensland, AU): 3 new FDA device listings, incl. system, x-ray, tomography, computed
• Merit Medical Australia Pty Ltd. (foreign exporter, Braiside Victoria, AU): 6 new FDA device listings, incl. catheter, embolectomy
• Omniscient Neurotechnology PTY Ltd (O8t) (manufacturer, Haymarket New South Wales, AU): 2 new FDA device listings, incl. system, image processing, radiological
• Signature Orthopaedics PTY Limited (manufacturer, Sydney New South Wales, AU): 12 new FDA device listings, incl. prosthesis, hip, femoral, resurfacing

BB

• Imperial Trading Limited (foreign exporter, Bridgetown Saint Michael, BB): 9 new FDA device listings, incl. bag, urine collection, leg, for external use, sterile

California

• 15445361 Canada Inc. (foreign exporter, Shawinigan Quebec, CA): 25 new FDA device listings, incl. container, liquid medication, graduated
• Ads Dental System Inc. (repackager or relabeler, Ontario, CA): 7 new FDA device listings, incl. controller, foot, handpiece and cord
• Advanced Imaging Services, Inc. (repackager or relabeler, Lathrop, CA): 7 new FDA device listings, incl. tomographic imager combining emission computed tomography with nuclear
• 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
• Alcon Research, LLC (manufacturer, Irvine, CA): 2 new FDA device listings, incl. laser, ophthalmic
• Alcon Research, LLC (specification developer, Lake Forest, CA): 2 new FDA device listings, incl. laser, ophthalmic
• Align Technology, Inc. (specification developer, San Jose, CA): 3 new FDA device listings, incl. light transmission caries detector
• Alom Technologies Corporation (contract manufacturer, Fremont, CA): 2 new FDA device listings, incl. dna specimen collection, saliva
• Alphatec Spine, Inc. (manufacturer, Carlsbad, CA): 10 new FDA device listings, incl. system, image processing, radiological
• Amarigo Inc (manufacturer, Los Angeles, CA): 7 new FDA device listings, incl. pad, heating, powered
• AMD Medicom Inc. (manufacturer, Pointe-Claire, Montreal Quebec, CA): 9 new FDA device listings, incl. polymer patient examination glove
• Applied BioCode, Inc. (manufacturer, Santa Fe Springs, CA): 12 new FDA device listings, incl. instrumentation for clinical multiplex test systems
• Ark Diagnostics Inc (manufacturer, Fremont, CA): 2 new FDA device listings, incl. anti-factor xa activity test system, apixaban
• Auris Health, Inc (manufacturer, Santa Clara, CA): 3 new FDA device listings, incl. integrated operating table-electromechanical surgical system
• Auris Health, Inc. (manufacturer, San Jose, CA): 2 new FDA device listings, incl. system, x-ray, tomography, computed
• Autonomous Medical Devices Incorporated (manufacturer, Santa Ana, CA): 5 new FDA device listings, incl. assayed external control material for microbiology nucleic acid amplif
• Babylist, Inc. (repackager or relabeler, Emeryville, CA): 2 new FDA device listings, incl. pack, hot or cold, reusable
• Balt USA, LLC (manufacturer, Irvine, CA): 5 new FDA device listings, incl. catheter, percutaneous
• Becton Dickinson Canada Inc. (foreign exporter, Mississauga Ontario, CA): 12 new FDA device listings, incl. computer, diagnostic, programmable
• Beyes Dental Inc (manufacturer, Toronto Ontario, CA): 3 new FDA device listings, incl. gutta-percha
• Biocheck, Inc. (repackager or relabeler, Pleasant Hill, CA): 3 new FDA device listings, incl. helicobacter pylori
• BioticsAI, Inc. (manufacturer, San Francisco, CA): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Boston Aesthetics Inc (other, Irvine, CA): 7 new FDA device listings, incl. powered laser surgical instrument
• BTNX Inc. (repackager or relabeler, Pickering Ontario, CA): 11 new FDA device listings, incl. test, phencyclidine (pcp), over the counter
• Can Technomed Trading Ltd. (foreign exporter, Richmond British Columbia, CA): 40 new FDA device listings, incl. system, tomography, computed, emission
• Canadian Hospital Specialties Ltd. (contract manufacturer, OAKVILLE Ontario, CA): 12 new FDA device listings, incl. catheter, intravascular, therapeutic, long-term greater than 30 days
• Carlsmed, Inc. (manufacturer, Carlsbad, CA): 2 new FDA device listings, incl. appliance, fixation, spinal intervertebral body
• Cgbio USA, Inc. (repackager or relabeler, Irvine, CA): 47 new FDA device listings, incl. orthosis, spinal pedicle fixation
• Clarity Design, Inc. (contract manufacturer, Poway, CA): 2 new FDA device listings, incl. marker, radiographic, implantable
• Conavi Medical Inc (specification developer, Toronto Ontario, CA): 3 new FDA device listings, incl. system, imaging, optical coherence tomography (oct)
• Cutera, Inc. (manufacturer, Brisbane, CA): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Dexcom, Inc. (specification developer, San Diego, CA): 5 new FDA device listings, incl. tape and bandage, adhesive
• Diadent Group Intl., Inc. (foreign exporter, Vancouver British Columbia, CA): 6 new FDA device listings, incl. material, tooth shade, resin
• 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
• Diazyme Laboratories, Inc. (manufacturer, Poway, CA): 3 new FDA device listings, incl. lipoprotein, low-density, antigen, antiserum, control
• Endologix LLC (specification developer, Santa Rosa, CA): 3 new FDA device listings, incl. peripheral mechanical thrombectomy with aspiration
• Endovascular Engineering, Inc. (manufacturer, Menlo Park, CA): 3 new FDA device listings, incl. thrombectomy whole blood return system
• Engineering Cpr Inc. (contract manufacturer, mississauga Ontario, CA): 11 new FDA device listings, incl. orthopedic stereotaxic instrument
• Frontier Dental Supply Inc (foreign exporter, Aurora Ontario, CA): 12 new FDA device listings, incl. sealant, pit and fissure, and conditioner
• Fusionx Medtech Inc. (repackager or relabeler, Whittier, CA): 22 new FDA device listings, incl. instrument, manual, surgical, general use
• Gravitas Medical, Inc. (manufacturer, Berkeley, CA): 2 new FDA device listings, incl. tubes, gastrointestinal (and accessories)
• Gurin Products LLC (repackager or relabeler, Tustin, CA): 2 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter
• Happy Heart Care Services, LLC (repackager or relabeler, Menlo Park, CA): 2 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• HydraFacial LLC (repackager or relabeler, Long Beach, CA): 5 new FDA device listings, incl. stimulator, muscle, powered
• iCRco Inc. (repackager or relabeler, Goleta, CA): 5 new FDA device listings, incl. camera, multi format, radiological
• Icu Medical, Inc. (specification developer, San Clemente, CA): 223 new FDA device listings, incl. tube, tracheostomy (w/wo connector)
• Innopex Limited (foreign exporter, Toronto Ontario, CA): 89 new FDA device listings, incl. dressing, wound, occlusive
• Innovacyn, Inc. (manufacturer, Rialto, CA): 2 new FDA device listings, incl. dressing, wound, drug
• Inova Diagnostics, Inc. (manufacturer, San Diego, CA): 3 new FDA device listings, incl. system, test, anticardiolipin immunological
• Inquis Medical, Inc. (manufacturer, Menlo Park, CA): 5 new FDA device listings, incl. aspiration thrombectomy catheter
• Integrity United Inc Dba Costcare (other, Anaheim, CA): 3 new FDA device listings, incl. mattress, air flotation, alternating pressure
• Intuitive Surgical, Inc. (manufacturer, Santa Clara, CA): 9 new FDA device listings, incl. system, surgical, computer controlled instrument
• Intuitive Surgical, Inc. (manufacturer, Sunnyvale, CA): 9 new FDA device listings, incl. system, surgical, computer controlled instrument
• Isomedix Operations, Inc (contract sterilizer, Ontario, CA): 7 new FDA device listings, incl. plate, fixation, bone
• Isomedix Operations, Inc. (contract sterilizer, Temecula, CA): 7 new FDA device listings, incl. percutaneous catheter, ultrasound
• Jmu Dental, Inc (repackager or relabeler, Fullerton, CA): 31 new FDA device listings, incl. agent, tooth bonding, resin
• Karl Storz Endoscopy-America, Inc. (other, El Segundo, CA): 15 new FDA device listings, incl. endoscopic grasping/cutting instrument, non-powered
• Kash Sales Inc. (foreign exporter, Richmond Hill Ontario, CA): 15 new FDA device listings, incl. agent, absorbable hemostatic, collagen based
• Leica Biosystems Imaging, Inc. (manufacturer, Vista, CA): 3 new FDA device listings, incl. whole slide imaging system
• Life Science Outsourcing, Inc. (contract sterilizer, Brea, CA): 15 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical
• LifeSignals, Inc. (specification developer, Milpitas, CA): 4 new FDA device listings, incl. outpatient cardiac telemetry
• Lotfancy Inc (repackager or relabeler, Ontario, CA): 3 new FDA device listings, incl. dressing, wound, drug
• Masimo Corporation (manufacturer, Irvine, CA): 4 new FDA device listings, incl. transmitters and receivers, electrocardiograph, telephone
• Medinova Group Co. (manufacturer, Laguna Beach, CA): 21 new FDA device listings, incl. shield, eye, ophthalmic (including sunlamp protective eyewear and post
• Merit Medical Canada Ltd. (foreign exporter, Markham Ontario, CA): 6 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization
• Neptune Medical, Inc (manufacturer, Burlingame, CA): 3 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology
• Neurofield, Inc. (specification developer, Santa Barbara, CA): 3 new FDA device listings, incl. cranial electrotherapy stimulator to treat insomnia and/or anxiety
• Nihon Kohden America, Inc. (manufacturer, Irvine, CA): 5 new FDA device listings, incl. tape and bandage, adhesive
• Nucare LLC (specification developer, Montclair, CA): 4 new FDA device listings, incl. latex patient examination glove
• Optik K & R Inc. (contract manufacturer, Toronto Ontario, CA): 2 new FDA device listings, incl. lens, contact (other material) - daily
• OrthAlign, Inc. (manufacturer, Irvine, CA): 3 new FDA device listings, incl. intraoperative orthopedic joint assessment aid
• Pac-Dent Inc. (manufacturer, Brea, CA): 2 new FDA device listings, incl. system, optical impression, computer assisted design and manufacturing
• Paragon Implant Mfg., LLC (manufacturer, Calabasas, CA): 2 new FDA device listings, incl. abutment, implant, dental, endosseous
• Patterson Dental Canada Inc. (repackager or relabeler, Montreal Quebec, CA): 4 new FDA device listings, incl. device, caries detection
• 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
• Prism Pacific Industries LLC (repackager or relabeler, Sacramento, CA): 2 new FDA device listings, incl. protector, skin pressure
• Prismatik Dentalcraft, Inc. (manufacturer, Irvine, CA): 2 new FDA device listings, incl. resin, denture, relining, repairing, rebasing
• PROCEPT BioRobotics Corporation (manufacturer, San Jose, CA): 4 new FDA device listings, incl. fluid jet removal system
• Proguard Health Inc. (contract manufacturer, Los Angeles, CA): 5 new FDA device listings, incl. handpiece, air-powered, dental
• Providence Medical Technology, Inc. (manufacturer, Pleasanton, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument
• Ray Vision Inc. (specification developer, Lake Forest, CA): 18 new FDA device listings, incl. retinoscope, ac-powered
• Resmed Corp (manufacturer, San Diego, CA): 9 new FDA device listings, incl. accessory to continuous ventilator (respirator)
• Roche Molecular Systems, Inc. (specification developer, Pleasanton, CA): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system
• Serpex Medical, Inc. (specification developer, Santa Clara, CA): 2 new FDA device listings, incl. unit, cryosurgical, accessories
• Shenb America, Inc. (other, Brea, CA): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Si-Bone, Inc. (manufacturer, Santa Clara, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument
• Si-Bone, Inc. (other, Santa Clara, CA): 2 new FDA device listings, incl. orthopedic stereotaxic instrument
• Siemens Healthcare Limited (foreign exporter, Oakville Ontario, CA): 3 new FDA device listings, incl. digital breast tomosynthesis
• Sight Sciences, Inc. (specification developer, Menlo Park, CA): 3 new FDA device listings, incl. pump, infusion, ophthalmic
• Skyward Medical Devices LLC (repackager or relabeler, Eastvale, CA): 28 new FDA device listings, incl. shield, protective, personnel
• Spectrum Assembly Inc. (contract manufacturer, Carlsbad, CA): 5 new FDA device listings, incl. stimulator, spinal-cord, implanted (pain relief)
• Spinal Elements, Inc. (manufacturer, Carlsbad, CA): 3 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Sterigenics Radiation Technologies Canada, Inc (contract sterilizer, PORT COQUITLAM British Columbia, CA): 7 new FDA device listings, incl. table, operating-room, electrical
• Sterigenics Radiation Technologies, LLC (contract sterilizer, San Diego, CA): 6 new FDA device listings, incl. glucose range monitoring system
• Sterigenics U.S. LLC (contract sterilizer, Hayward, CA): 6 new FDA device listings, incl. system, facet screw spinal device
• Sterigenics U.S., LLC (contract sterilizer, Ontario, CA): 7 new FDA device listings, incl. integrated continuous glucose monitoring system, factory calibrated
• Sterigenics U.S., LLC (contract sterilizer, Tustin, CA): 7 new FDA device listings, incl. injector and syringe, angiographic
• Sterigenics US LLC (contract sterilizer, Los Angeles, CA): 8 new FDA device listings, incl. device, surgical, cryogenic
• SW Technologies Inc. (manufacturer, Union City, CA): 4 new FDA device listings, incl. polymer patient examination glove
• Tandem Diabetes Care, Inc. (manufacturer, San Diego, CA): 3 new FDA device listings, incl. interoperable automated glycemic controller
• Tecan Cdmo Solutions Mh, Corp. (contract manufacturer, Morgan Hill, CA): 3 new FDA device listings, incl. deformability cytometry for sepsis risk assessment
• Terumo Medical Canada, Inc. (foreign exporter, Vaughan Ontario, CA): 4 new FDA device listings, incl. prosthesis, vascular graft, of 6mm and greater diameter
• The Binding Site, Inc. (manufacturer, San Diego, CA): 6 new FDA device listings, incl. lambda, antigen, antiserum, control
• Tpc Advanced Technology, Inc. (repackager or relabeler, City Industry, CA): 4 new FDA device listings, incl. scanner, color
• Traferox Technologies Inc. (manufacturer, Mississauga Ontario, CA): 3 new FDA device listings, incl. system, perfusion, kidney
• Trelleborg Sealing Solutions Us, Inc. (contract manufacturer, Paso Robles, CA): 3 new FDA device listings, incl. implant, eye valve
• Trimed, Inc. (manufacturer, Santa Clarita, CA): 4 new FDA device listings, incl. screw, fixation, bone
• Universal Brain Inc. (specification developer, Palo Alto, CA): 3 new FDA device listings, incl. stimulator, auditory, evoked response
• UPS Supply Chain Solutions, Inc. (repackager or relabeler, Mira Loma, CA): 4 new FDA device listings, incl. enzyme linked immunoabsorbent assay, rubeola igg
• Valencia Technologies Corporation (manufacturer, Valencia, CA): 4 new FDA device listings, incl. stimulator, tibial, electrical, implantable, for urinary incontinence
• Venus Concept Inc. (manufacturer, San Jose, CA): 7 new FDA device listings, incl. powered light based non-laser surgical instrument with thermal effect
• Victorch Meditek, Inc. (manufacturer, San Diego, CA): 15 new FDA device listings, incl. applicator, absorbent tipped, sterile
• W&H Impex Inc. (foreign exporter, Windsor Ontario, CA): 8 new FDA device listings, incl. sterilizer, steam
• Zyris, Inc. (manufacturer, Santa Barbara, CA): 3 new FDA device listings, incl. drape, surgical, exempt

CN

• Aena Medical (Jiangsu) Co.,Ltd. (contract manufacturer, Jiangyin City Jiangsu, CN): 3 new FDA device listings, incl. needle, hypodermic, single lumen
• Allmed Industrial Limited (manufacturer, Shenzhen City Guangdong, CN): 5 new FDA device listings, incl. polymer patient examination glove
• Allmed Medical Products Co., Ltd. (contract manufacturer, Zhijiang City Hubei, CN): 5 new FDA device listings, incl. vinyl patient examination glove
• Allwin First Aid Supplies Taizhou Co., Ltd (manufacturer, Taizhou Jiangsu, CN): 3 new FDA device listings, incl. vinyl patient examination glove
• Alton Shanghai Medical Instruments Co Ltd (manufacturer, Shanghai, CN): 3 new FDA device listings, incl. device, measuring, for panendoscope
• Amphenol Medical Technologies (Dongguan) Co., Ltd. (contract manufacturer, Dongguan Guangdong, CN): 2 new FDA device listings, incl. computer, diagnostic, programmable
• Andon Medical co., LTD (contract manufacturer, Tianjin, CN): 2 new FDA device listings, incl. multi-analyte respiratory virus antigen detection test
• Anhui Kangfu Industrial Foreign Trade Co.,Ltd (manufacturer, Tianchang Anhui, CN): 5 new FDA device listings, incl. helmet, cranial, for protective use
• Anqing Clean Dental Instrument Technology Co.,Ltd (manufacturer, Anqing City Anhui, CN): 47 new FDA device listings, incl. cotton, roll
• Assure Tech. (Hangzhou) Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. sperm, antigen, antiserum, control
• Assure Tech. (Hangzhou) Co., Ltd. (manufacturer, Hangzhou Zhejiang, CN): 3 new FDA device listings, incl. sperm, antigen, antiserum, control
• Beijing Infervision Healthcare Medical Technology Co., Ltd. (manufacturer, Beijing, CN): 3 new FDA device listings, incl. automated radiological image processing software
• Beijing Konted Medical Technology Co., Ltd (manufacturer, Beijing, CN): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Beijing Nubway S&T Co.,Ltd. (manufacturer, Beijing, CN): 4 new FDA device listings, incl. powered laser surgical instrument
• Beijing Sanhe Laser Co., Ltd. (foreign exporter, Beijing, CN): 6 new FDA device listings, incl. powered laser surgical instrument
• Beijing Spiritlaser Science & Technology Co., Ltd. (manufacturer, Beijing, CN): 3 new FDA device listings, incl. powered laser surgical instrument
• Beijing Winkonlaser Technology Limited (manufacturer, Beijing, CN): 5 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• 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
• Bioteke Corporation (Wuxi) Co., Ltd (manufacturer, Wuxi City Jiangsu, CN): 10 new FDA device listings, incl. test, opiates, over the counter
• Boen Healthcare Co., Ltd. (specification developer, Suzhou Jiangsu, CN): 125 new FDA device listings, incl. apparatus, suction, operating-room, wall vacuum powered
• Canyon Medical Inc. (manufacturer, Nanjing Jiangsu, CN): 2 new FDA device listings, incl. catheter, nephrostomy, general & plastic surgery
• Carestream Healthcare International Company, Ltd (contract manufacturer, Shanghai, CN): 4 new FDA device listings, incl. generator, high-voltage, x-ray, diagnostic
• Changshu Rozer Sterilization Technology Co., Ltd. (contract sterilizer, Changshu Jiangsu, CN): 2 new FDA device listings, incl. evacuator, bladder, manually operated
• Changzhou Atomic Hi-Tech Radiation Co., Ltd. (contract sterilizer, CHANGZHOU Jiangsu, CN): 3 new FDA device listings, incl. anti fog solution and accessories, endoscopy
• Changzhou Biomet Medical Devices Co., Ltd. (contract manufacturer, Changzhou City Jiangsu, CN): 8 new FDA device listings, incl. plate, bone
• Changzhou Newmed Micro-Medtech Co., Ltd. (manufacturer, Changzhou City Jiangsu, CN): 3 new FDA device listings, incl. accessories, catheter
• Chengdu Cryo-Push Medical Technology Co.,Ltd (manufacturer, CHENGDU Sichuan, CN): 4 new FDA device listings, incl. pack, hot or cold, reusable
• CHISON Medical Technologies Co., Ltd. (manufacturer, WUXI Jiangsu, CN): 3 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic
• Conod Medical Co.,Limited (contract manufacturer, Changshu Jiangsu, CN): 2 new FDA device listings, incl. irrigation kit (wounds)
• Conod Medical Shuyang Co., Ltd. (contract manufacturer, Shuyang Jiangsu, CN): 3 new FDA device listings, incl. adaptor, ureteral catheter
• Deepintec Scientific Co., Ltd (manufacturer, Beijing, CN): 6 new FDA device listings, incl. wire, guide, catheter
• Denjoy Dental Co., Ltd (manufacturer, Changsha city Hunan, CN): 2 new FDA device listings, incl. endodontic kit
• Dentalmaster (Xiamen) Medical Technology Co., Ltd. (manufacturer, Xiamen Fujian, CN): 25 new FDA device listings, incl. explorer, operative
• Depuy Synthes (Suzhou) Medical Devices Co., Ltd. (manufacturer, SUZHOU Jiangsu, CN): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol
• Devon Medical Products (Jiangsu) Ltd (repackager or relabeler, Nantong Jiangsu, CN): 3 new FDA device listings, incl. stocking, medical support (for general medical purposes)
• Dikaku Industrial Co.,Limited (manufacturer, Hong Kong, CN): 3 new FDA device listings, incl. pack, hot or cold, reusable
• Dong Guan Jia Shuan Industrial Co., Ltd (manufacturer, Dongguan Guangdong, CN): 5 new FDA device listings, incl. cushion, flotation
• Dongguan Bao Kang Dian Zi Ke Ji Limited (contract manufacturer, Dongguan City Guangdong, CN): 3 new FDA device listings, incl. arthroscope
• Dongguan Lee-Mat Sports Technology Co., Ltd (manufacturer, Dongguan Guangdong, CN): 4 new FDA device listings, incl. orthosis, limb brace
• Dongguan Letme Medical Technology Co., Ltd. (manufacturer, Dongguan Guangdong, CN): 3 new FDA device listings, incl. light based over-the-counter hair removal
• Dongguan Miqiang Technology Co., Ltd (contract manufacturer, Dongguan Guangdong, CN): 4 new FDA device listings, incl. accessory, surgical apparel
• Dongguan Paidaxing Technology Co., Ltd (manufacturer, Dongguan City Guangdong, CN): 3 new FDA device listings, incl. massager, therapeutic, electric
• Dongguan Quanding Medical Supplies Co., Ltd (manufacturer, Dongguan Guangdong, CN): 7 new FDA device listings, incl. unit, heating, powered
• Dongyang City Yonoel Outdoor Products Co.,Ltd (contract manufacturer, Dongyang Zhejiang, CN): 2 new FDA device listings, incl. mouthpiece, breathing
• Edan Instruments, Inc. (contract manufacturer, Shenzhen Guangdong, CN): 13 new FDA device listings, incl. monitor, physiological, patient(with arrhythmia detection or alarms)
• Eternal (Shanghai) Medical Technology Co., Ltd. (contract sterilizer, Shanghai, CN): 2 new FDA device listings, incl. dislodger, stone, flexible
• Exceldent Dental Technology Development Co., Ltd. (contract manufacturer, Zhuhai Guangdong, CN): 2 new FDA device listings, incl. bracket, plastic, orthodontic
• Ezisurg Medical Co., Ltd. (manufacturer, Shanghai, CN): 2 new FDA device listings, incl. staple, implantable
• Fesun Shanghai Co., Ltd. (manufacturer, shanghai, CN): 7 new FDA device listings, incl. tape and bandage, adhesive
• Flexicare Medical (Dongguan) Ltd. (contract manufacturer, DONGGUAN CITY Guangdong, CN): 2 new FDA device listings, incl. bronchoscope (flexible or rigid)
• Fofo Medical Co.,Ltd (foreign exporter, Xiamen Fujian, CN): 20 new FDA device listings, incl. exerciser, finger, powered
• Foshan Fricheer Medical Technology Co.,Ltd (manufacturer, Foshan City Guangdong, CN): 7 new FDA device listings, incl. adaptor, hygiene
• Foshan Haiseer Electronic Technology Co., Ltd. (manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. bandage, elastic
• Foshan Hongfeng Co.,Ltd (contract manufacturer, Foshan Guangdong, CN): 2 new FDA device listings, incl. sleeve, limb, compressible
• Foshan Pingchuang Medical Technology Co., Ltd (manufacturer, Foshan City Guangdong, CN): 4 new FDA device listings, incl. media, coupling, ultrasound
• Foshan Shiding Technology Co., Ltd. (contract manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. stimulator, transcutaneous electrical, aesthetic purposes
• Foshan Soco Precision Instrument Co.,Ltd. (manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. loupe, diagnostic/surgical
• Foshan Topmed Dental Co., Ltd. (manufacturer, Foshan Guangdong, CN): 3 new FDA device listings, incl. handpiece, air-powered, dental
• Fujian Unisoft Hygiene Products Co.,Ltd (manufacturer, Quanzhou Fujian, CN): 3 new FDA device listings, incl. garment, protective, for incontinence
• Gauke (Hubei) Healthcare Co., Ltd (foreign exporter, Huanggang City Hubei, CN): 4 new FDA device listings, incl. polymer patient examination glove
• Gauke International Trading Co., Ltd. (foreign exporter, Wuhan Hubei, CN): 5 new FDA device listings, incl. mask, surgical
• Gcmedica Enterprise Ltd.(Wuxi) (manufacturer, WUXI Jiangsu, CN): 3 new FDA device listings, incl. applicator, vaginal

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