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- Page 3

# DeviceEstablishmentPulse: all 1,000 record reports, page 3 of 5

Every DeviceEstablishmentPulse record report, 200 per page, grouped by state. Records 401 to 600: Karl Storz Se & Co. Kg (contract manufacturer, TUTTLINGEN Baden-Wurttemberg, DE): 6 new FDA device listings, incl. hysteroscope (and accessories) to Wipro Ge Medical Device Manufacturing Private Limited (manufacturer, Bangalore Karnataka, IN): 19 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

[1](/hub/deviceestablishmentpulse/records) [2](/hub/deviceestablishmentpulse/records/2) 3 [4](/hub/deviceestablishmentpulse/records/4) [5](/hub/deviceestablishmentpulse/records/5)

## Delaware

- [Karl Storz Se & Co. Kg (contract manufacturer, TUTTLINGEN Baden-Wurttemberg, DE): 6 new FDA device listings, incl. hysteroscope (and accessories)](/report/deviceestablishmentpulse/karl-storz-se-and-co-kg-tuttlingen-baden-wurttemberg-de--fdaest-9610617-2026-09-28)
- [Kettenbach GmbH & Co Kg (manufacturer, ESCHENBURG Hesse, DE): 2 new FDA device listings, incl. agent, polishing, abrasive, oral cavity](/report/deviceestablishmentpulse/kettenbach-gmbh-and-co-kg-eschenburg-hesse-de--fdaest-9681356-2026-09-09)
- [Leraise Health International LLC (other, Dover, DE): 3 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive](/report/deviceestablishmentpulse/leraise-health-international-llc-dover-de--fdaest-3045492872-2026-06-23)
- [Medi.Plan GmbH & Co. Kg (foreign exporter, Dortmund North Rhine-Westphalia, DE): 14 new FDA device listings, incl. drill, surgical, ent (electric or pneumatic) including handpiece](/report/deviceestablishmentpulse/medi-plan-gmbh-and-co-kg-dortmund-north-rhine-westphali-de--fdaest-3033536319-2026-08-31)
- [Nessa Global Inc. (specification developer, Dover, DE): 2 new FDA device listings, incl. lipoaspirate washing system for aesthetic body contouring](/report/deviceestablishmentpulse/nessa-global-inc-dover-de--fdaest-3043022296-2026-08-13)
- [Rhenus Se & Co. Kg (foreign exporter, Holzwickede North Rhine-Westphalia, DE): 11 new FDA device listings, incl. introducer, catheter](/report/deviceestablishmentpulse/rhenus-se-and-co-kg-holzwickede-north-rhine-westph-de--fdaest-3014656749-2026-05-05)
- [Siemens Healthcare Diagnostics Inc. (manufacturer, Newark, DE): 3 new FDA device listings, incl. bilirubin (total and unbound) in the neonate test system](/report/deviceestablishmentpulse/siemens-healthcare-diagnostics-inc-newark-de--fdaest-2517506-2026-08-24)
- [Stryker Leibinger GmbH & Co. Kg (manufacturer, FREIBURG Baden-Wurttemberg, DE): 5 new FDA device listings, incl. drill, bone, powered](/report/deviceestablishmentpulse/stryker-leibinger-gmbh-and-co-kg-freiburg-baden-wurttemberg-de--fdaest-8010177-2026-10-12)
- [Titanlinks Logistics LLC (repackager or relabeler, Newark, DE): 336 new FDA device listings, incl. scaler, ultrasonic](/report/deviceestablishmentpulse/titanlinks-logistics-llc-newark-de--fdaest-3044819802-2026-10-06)
- [Waldemar Link GmbH & Co. KG (manufacturer, Norderstedt Schleswig-Holstein, DE): 4 new FDA device listings, incl. prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-po](/report/deviceestablishmentpulse/waldemar-link-gmbh-and-co-kg-norderstedt-schleswig-holstein-de--fdaest-3004371426-2026-07-07)

## DO

- [STERIS Corporation de Republica Dominicana, S.R.L. (contract sterilizer, Santo Domingo, DO): 3 new FDA device listings, incl. system, x-ray, mammographic](/report/deviceestablishmentpulse/steris-corporation-de-republica-dominicana-s-r-l-santo-domingo-do--fdaest-3017636737-2026-08-17)

## ES

- [B.T.I. Biotechnology Institute, S.L. (foreign exporter, Miñano Alava, ES): 3 new FDA device listings, incl. syringe, antistick](/report/deviceestablishmentpulse/b-t-i-biotechnology-institute-s-l-minano-alava-es--fdaest-3004417597-2026-06-16)

## Florida

- [Advance-Esthetic LLC (other, Fort Lauderdale, FL): 8 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/advance-esthetic-llc-fort-lauderdale-fl--fdaest-3013397886-2026-10-12)
- [Apyx Medical Corporation (manufacturer, Clearwater, FL): 2 new FDA device listings, incl. system, suction, lipoplasty for removal](/report/deviceestablishmentpulse/apyx-medical-corporation-clearwater-fl--fdaest-3007593903-2026-08-24)
- [Arthrex, Inc. (contract manufacturer, Ave Maria, FL): 10 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/arthrex-inc-ave-maria-fl--fdaest-3010331645-2026-09-27)
- [Arthrex, Inc. (specification developer, Naples, FL): 12 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/arthrex-inc-naples-fl--fdaest-1220246-2026-09-27)
- [Aso LLC (other, Sarasota, FL): 3 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/aso-llc-sarasota-fl--fdaest-1038758-2026-09-01)
- [Aurora Dermo Corp (repackager or relabeler, Miami, FL): 9 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/aurora-dermo-corp-miami-fl--fdaest-3039935725-2026-08-11)
- [Cerenovus, Inc. (manufacturer, Miami, FL): 5 new FDA device listings, incl. device, neurovascular embolization](/report/deviceestablishmentpulse/cerenovus-inc-miami-fl--fdaest-3007628272-2026-09-30)
- [CQ Decimal, LLC (manufacturer, Sanford, FL): 14 new FDA device listings, incl. block, beam-shaping, radiation therapy](/report/deviceestablishmentpulse/cq-decimal-llc-sanford-fl--fdaest-3003586672-2026-05-28)
- [EmCyte Corporation (specification developer, Fort Myers, FL): 2 new FDA device listings, incl. powered microneedle device](/report/deviceestablishmentpulse/emcyte-corporation-fort-myers-fl--fdaest-1066491-2026-09-25)
- [Exactech, Inc. (manufacturer, Gainesville, FL): 5 new FDA device listings, incl. prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-po](/report/deviceestablishmentpulse/exactech-inc-gainesville-fl--fdaest-1038671-2026-07-02)
- [First Nation Group, LLC (specification developer, Saint Petersburg, FL): 2 new FDA device listings, incl. mattress, flotation therapy, non-powered](/report/deviceestablishmentpulse/first-nation-group-llc-saint-petersburg-fl--fdaest-3039346864-2026-08-14)
- [Forsure Medical Products LLC. (repackager or relabeler, Doral, FL): 10 new FDA device listings, incl. tube, tracheostomy (w/wo connector)](/report/deviceestablishmentpulse/forsure-medical-products-llc-doral-fl--fdaest-3005609751-2026-06-16)
- [Gfa Production Inc (specification developer, Clearwater, FL): 25 new FDA device listings, incl. finger cot](/report/deviceestablishmentpulse/gfa-production-inc-clearwater-fl--fdaest-3045526618-2026-07-31)
- [Glownar Aesthetics. LLC (specification developer, Davie, FL): 10 new FDA device listings, incl. brush, dermabrasion, powered](/report/deviceestablishmentpulse/glownar-aesthetics-llc-davie-fl--fdaest-3022327202-2026-09-24)
- [Hc Biologics LLC (manufacturer, Miami, FL): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, cervical](/report/deviceestablishmentpulse/hc-biologics-llc-miami-fl--fdaest-3007604895-2026-05-14)
- [Headsafe US INC (other, Lake Mary, FL): 2 new FDA device listings, incl. reduced- montage standard electroencephalograph](/report/deviceestablishmentpulse/headsafe-us-inc-lake-mary-fl--fdaest-3048720912-2026-08-25)
- [Iradimed Corporation (manufacturer, Orlando, FL): 3 new FDA device listings, incl. set, i.v. fluid transfer](/report/deviceestablishmentpulse/iradimed-corporation-orlando-fl--fdaest-3005053560-2026-05-05)
- [Merits Health Products., Inc. (repackager or relabeler, Fort Myers, FL): 5 new FDA device listings, incl. powered stairway chair lift](/report/deviceestablishmentpulse/merits-health-products-inc-fort-myers-fl--fdaest-1058069-2026-07-14)
- [Metier Medical (USA) LLC (other, Ponte Vedra Beach, FL): 7 new FDA device listings, incl. needle, aspiration and injection, disposable](/report/deviceestablishmentpulse/metier-medical-usa-llc-ponte-vedra-beach-fl--fdaest-3010405396-2026-10-16)
- [Oketz Logistics LLC (repackager or relabeler, Coral Gables, FL): 56 new FDA device listings, incl. sterilization wrap containers, trays, cassettes & other accessories](/report/deviceestablishmentpulse/oketz-logistics-llc-coral-gables-fl--fdaest-3038718579-2026-10-12)
- [Ortho Max Inc (other, Palm City, FL): 14 new FDA device listings, incl. orthopedic manual surgical instrument](/report/deviceestablishmentpulse/ortho-max-inc-palm-city-fl--fdaest-3013843230-2026-08-26)
- [Osteomni Inc (specification developer, Miami, FL): 5 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical](/report/deviceestablishmentpulse/osteomni-inc-miami-fl--fdaest-3041915189-2026-05-22)
- [Prabadin Corp (other, Miami, FL): 23 new FDA device listings, incl. visual, pregnancy hcg, prescription use](/report/deviceestablishmentpulse/prabadin-corp-miami-fl--fdaest-3016659819-2026-07-24)
- [Sentinel Medical Technologies, LLC (manufacturer, Jacksonville, FL): 2 new FDA device listings, incl. intra-abdominal pressure monitoring device](/report/deviceestablishmentpulse/sentinel-medical-technologies-llc-jacksonville-fl--fdaest-3021468326-2026-09-21)
- [Shapes Secrets LLC (repackager or relabeler, Doral, FL): 5 new FDA device listings, incl. bedding, disposable, medical](/report/deviceestablishmentpulse/shapes-secrets-llc-doral-fl--fdaest-3036497112-2026-05-13)
- [Stellmacher Instruments Inc (repackager or relabeler, Orlando, FL): 30 new FDA device listings, incl. handle, scalpel](/report/deviceestablishmentpulse/stellmacher-instruments-inc-orlando-fl--fdaest-3029754081-2026-09-24)
- [Strauss Surgical USA LLC. (repackager or relabeler, Doral, FL): 2 new FDA device listings, incl. endoscopic grasping/cutting instrument, non-powered, exempt](/report/deviceestablishmentpulse/strauss-surgical-usa-llc-doral-fl--fdaest-3008816725-2026-08-26)
- [Structure Medical, LLC. (contract manufacturer, Naples, FL): 27 new FDA device listings, incl. appliance, fixation, spinal interlaminal](/report/deviceestablishmentpulse/structure-medical-llc-naples-fl--fdaest-3006783837-2026-09-15)
- [Summit Orthopedic Technologies Inc. (contract manufacturer, Naples, FL): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar](/report/deviceestablishmentpulse/summit-orthopedic-technologies-inc-naples-fl--fdaest-3012491394-2026-09-11)
- [Surgentec LLC (manufacturer, Boca Raton, FL): 15 new FDA device listings, incl. system, facet screw spinal device](/report/deviceestablishmentpulse/surgentec-llc-boca-raton-fl--fdaest-3012495575-2026-10-16)
- [Surgipros LLC (repackager or relabeler, Palmetto, FL): 29 new FDA device listings, incl. elevator, ent](/report/deviceestablishmentpulse/surgipros-llc-palmetto-fl--fdaest-3012267976-2026-09-15)
- [Toyo Medical Co. (repackager or relabeler, Doral, FL): 2 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning](/report/deviceestablishmentpulse/toyo-medical-co-doral-fl--fdaest-1054713-2026-10-07)
- [VIVE Health LLC (repackager or relabeler, Naples, FL): 10 new FDA device listings, incl. wheelchair, powered](/report/deviceestablishmentpulse/vive-health-llc-naples-fl--fdaest-3011191255-2026-10-14)
- [Zapalign LLC (repackager or relabeler, Fort Lauderdale, FL): 54 new FDA device listings, incl. mask, gas, anesthetic](/report/deviceestablishmentpulse/zapalign-llc-fort-lauderdale-fl--fdaest-3043226252-2026-09-16)
- [ZimVie US Corp LLC (contract manufacturer, Palm Beach Gardens, FL): 5 new FDA device listings, incl. abutment, implant, dental, endosseous](/report/deviceestablishmentpulse/zimvie-us-corp-llc-palm-beach-gardens-fl--fdaest-1038806-2026-05-14)

## GB

- [Ad Supply Group Limited (foreign exporter, London London, City of, GB): 39 new FDA device listings, incl. drills, burrs, trephines & accessories (simple, powered)](/report/deviceestablishmentpulse/ad-supply-group-limited-london-london-city-of-gb--fdaest-3030733800-2026-10-13)
- [Andersen Caledonia Ltd (contract sterilizer, Bellshill Scotland, GB): 4 new FDA device listings, incl. protector, ostomy](/report/deviceestablishmentpulse/andersen-caledonia-ltd-bellshill-scotland-gb--fdaest-3004530184-2026-09-26)
- [Bioliberty Ltd (specification developer, Edinburgh Edinburgh, City of, GB): 2 new FDA device listings, incl. interactive rehabilitation exercise device, prescription use](/report/deviceestablishmentpulse/bioliberty-ltd-edinburgh-edinburgh-city-of-gb--fdaest-3032772580-2026-09-25)
- [Cme Devices Ltd (contract manufacturer, CHEPSTOW Monmouthshire, GB): 9 new FDA device listings, incl. system, ablation, microwave and accessories](/report/deviceestablishmentpulse/cme-devices-ltd-chepstow-monmouthshire-gb--fdaest-3049783176-2026-08-03)
- [Corin Limited (manufacturer, CIRENCESTER Gloucestershire, GB): 5 new FDA device listings, incl. prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented](/report/deviceestablishmentpulse/corin-limited-cirencester-gloucestershire-gb--fdaest-9614209-2026-08-19)
- [Current Health Ltd (specification developer, Edinburgh Edinburgh, City of, GB): 6 new FDA device listings, incl. spirometer, diagnostic](/report/deviceestablishmentpulse/current-health-ltd-edinburgh-edinburgh-city-of-gb--fdaest-3015134004-2026-06-09)
- [Depuy Intl., Ltd. (manufacturer, Leeds, GB): 4 new FDA device listings, incl. bone cement](/report/deviceestablishmentpulse/depuy-intl-ltd-leeds-gb--fdaest-8010379-2026-06-15)
- [Digital Surgery Limited (manufacturer, London London, City of, GB): 2 new FDA device listings, incl. software controlled endoscope and instrument holder](/report/deviceestablishmentpulse/digital-surgery-limited-london-london-city-of-gb--fdaest-3017296423-2026-09-10)
- [Flexicare Medical Ltd. (specification developer, RHONDDA CYNON TAFF Wales, GB): 2 new FDA device listings, incl. cart, emergency, cardiopulmonary (excluding equipment)](/report/deviceestablishmentpulse/flexicare-medical-ltd-rhondda-cynon-taff-wales-gb--fdaest-8021995-2026-09-04)
- [Immunodiagnostic Systems Ltd. (manufacturer, Boldon Colliery Durham, GB): 4 new FDA device listings, incl. extractable antinuclear antibody, antigen and control](/report/deviceestablishmentpulse/immunodiagnostic-systems-ltd-boldon-colliery-durham-gb--fdaest-8021924-2026-09-04)
- [Loudwater Trade Finance Ltd (foreign exporter, LONDON England, GB): 3 new FDA device listings, incl. tube, tracheostomy (w/wo connector)](/report/deviceestablishmentpulse/loudwater-trade-finance-ltd-london-england-gb--fdaest-3012026312-2026-10-09)
- [Mast Group Ltd. (manufacturer, BOOTLE, MERSEYSIDE Liverpool, GB): 3 new FDA device listings, incl. susceptibility test discs, antimicrobial](/report/deviceestablishmentpulse/mast-group-ltd-bootle-merseyside-liverpool-gb--fdaest-8020667-2026-08-25)
- [Merit Medical UK Limited (foreign exporter, Earley Reading, GB): 6 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization](/report/deviceestablishmentpulse/merit-medical-uk-limited-earley-reading-gb--fdaest-3015309643-2026-08-20)
- [Odin Medical Limited (manufacturer, London London, City of, GB): 2 new FDA device listings, incl. gastrointesinal lesion software detection system](/report/deviceestablishmentpulse/odin-medical-limited-london-london-city-of-gb--fdaest-3031983124-2026-09-18)
- [Optikal (Southgate) Ltd (foreign exporter, Borehamwood, GB): 3 new FDA device listings, incl. lenses, soft contact, extended wear](/report/deviceestablishmentpulse/optikal-southgate-ltd-borehamwood-gb--fdaest-3044710860-2026-10-13)
- [Pilson Direct Trading Limited (foreign exporter, Newcastle Newcastle upon Tyne, GB): 11 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic](/report/deviceestablishmentpulse/pilson-direct-trading-limited-newcastle-newcastle-upon-tyne-gb--fdaest-3011763071-2026-06-23)
- [Platinum Focus Group Ltd. (foreign exporter, London London, City of, GB): 16 new FDA device listings, incl. orthosis, lumbo-sacral](/report/deviceestablishmentpulse/platinum-focus-group-ltd-london-london-city-of-gb--fdaest-3030446844-2026-09-16)
- [Probo Medical Ltd (foreign exporter, Gloucester Gloucestershire, GB): 19 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology](/report/deviceestablishmentpulse/probo-medical-ltd-gloucester-gloucestershire-gb--fdaest-3010398867-2026-09-22)
- [Purebrand Slutions Ltd (foreign exporter, London England, GB): 71 new FDA device listings, incl. insufflator, laparoscopic](/report/deviceestablishmentpulse/purebrand-slutions-ltd-london-england-gb--fdaest-3041276591-2026-09-17)
- [Smith & Nephew Medical Ltd (specification developer, HULL East Riding of Yorkshire, GB): 6 new FDA device listings, incl. negative pressure wound therapy powered suction pump](/report/deviceestablishmentpulse/smith-and-nephew-medical-ltd-hull-east-riding-of-yorkshire-gb--fdaest-8043484-2026-10-07)
- [Spectrum Medical Ltd (manufacturer, GLOUCESTER Gloucestershire, GB): 3 new FDA device listings, incl. control, pump speed, cardiopulmonary bypass](/report/deviceestablishmentpulse/spectrum-medical-ltd-gloucester-gloucestershire-gb--fdaest-3006073153-2026-09-09)
- [Sterigenics Uk Limited (contract sterilizer, Chesterfield Derbyshire, GB): 3 new FDA device listings, incl. filler, bone void, calcium compound](/report/deviceestablishmentpulse/sterigenics-uk-limited-chesterfield-derbyshire-gb--fdaest-3015219237-2026-07-07)
- [Summit Medical Ltd. (foreign exporter, Gloucestershire, GB): 2 new FDA device listings, incl. instrument, surgical, orthopedic, pneumatic powered & accessory/attach](/report/deviceestablishmentpulse/summit-medical-ltd-gloucestershire-gb--fdaest-9617155-2026-09-18)
- [Synergy Health Sterilisation UK Ltd (contract sterilizer, Berkshire Reading, GB): 28 new FDA device listings, incl. prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-berkshire-reading-gb--fdaest-3002807310-2026-10-15)
- [Synergy Health Sterilisation Uk Ltd (contract sterilizer, Daventry Northamptonshire, GB): 4 new FDA device listings, incl. orthopedic tray](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-daventry-northamptonshire-gb--fdaest-3002807315-2026-09-09)
- [Synergy Health Sterilisation UK Ltd (contract sterilizer, Thorne Doncaster, GB): 4 new FDA device listings, incl. barrier, animal source, intraoral](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-thorne-doncaster-gb--fdaest-3010155661-2026-06-08)
- [Synergy Health Sterilisation UK Ltd (contract sterilizer, West Yorkshire Bradford, GB): 7 new FDA device listings, incl. prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-po](/report/deviceestablishmentpulse/synergy-health-sterilisation-uk-ltd-west-yorkshire-bradford-gb--fdaest-3010155648-2026-09-09)
- [Systagenix Wound Management Manufacturing Limited (contract manufacturer, North Yorkshire, GB): 7 new FDA device listings, incl. sterilant, medical devices](/report/deviceestablishmentpulse/systagenix-wound-management-manufacturing-limited-north-yorkshire-gb--fdaest-3007663067-2026-09-16)
- [The Beauty Tech Group Ltd (specification developer, Macclesfield Cheshire East, GB): 3 new FDA device listings, incl. over-the-counter powered light based laser for acne](/report/deviceestablishmentpulse/the-beauty-tech-group-ltd-macclesfield-cheshire-east-gb--fdaest-3014737458-2026-07-24)
- [Veenak International Limited (foreign exporter, Birmingham, GB): 3 new FDA device listings, incl. spirometer, diagnostic](/report/deviceestablishmentpulse/veenak-international-limited-birmingham-gb--fdaest-3013298431-2026-08-30)
- [Venture Healthcare Ltd (foreign exporter, London London, City of, GB): 2 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/venture-healthcare-ltd-london-london-city-of-gb--fdaest-3030909446-2026-09-02)
- [Xiros Ltd (contract manufacturer, YEADON Leeds, GB): 3 new FDA device listings, incl. mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon](/report/deviceestablishmentpulse/xiros-ltd-yeadon-leeds-gb--fdaest-8044102-2026-09-02)

## Georgia

- [Boston Scientific Corporation (manufacturer, Roswell, GA): 5 new FDA device listings, incl. mesh, surgical, polymeric](/report/deviceestablishmentpulse/boston-scientific-corporation-roswell-ga--fdaest-3005619880-2026-09-22)
- [C.R. Bard, Inc. (contract sterilizer, Covington, GA): 11 new FDA device listings, incl. plethysmograph, impedance](/report/deviceestablishmentpulse/c-r-bard-inc-covington-ga--fdaest-1018233-2026-09-23)
- [C.R. Bard, Inc. (contract sterilizer, Madison, GA): 10 new FDA device listings, incl. catheter, flow directed](/report/deviceestablishmentpulse/c-r-bard-inc-madison-ga--fdaest-3006082230-2026-10-14)
- [CHS USA Incorporated (specification developer, Peachtree City, GA): 2 new FDA device listings, incl. syringe, piston](/report/deviceestablishmentpulse/chs-usa-incorporated-peachtree-city-ga--fdaest-3006450239-2026-08-13)
- [Dornier Medtech America, Inc. (other, Kennesaw, GA): 4 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid](/report/deviceestablishmentpulse/dornier-medtech-america-inc-kennesaw-ga--fdaest-1037955-2026-06-12)
- [Drive Northpoint, LLC (manufacturer, Palmetto, GA): 26 new FDA device listings, incl. unit, filter, membrane](/report/deviceestablishmentpulse/drive-northpoint-llc-palmetto-ga--fdaest-3044563261-2026-05-26)
- [Emsere, Inc. (repackager or relabeler, Peachtree City, GA): 11 new FDA device listings, incl. camera, ophthalmic, slit-scanning](/report/deviceestablishmentpulse/emsere-inc-peachtree-city-ga--fdaest-3010082909-2026-09-14)
- [Hsg-S Corp (manufacturer, Savannah, GA): 20 new FDA device listings, incl. carrier, amalgam, operative](/report/deviceestablishmentpulse/hsg-s-corp-savannah-ga--fdaest-3042866301-2026-08-28)
- [Machining Midtown LLC (contract manufacturer, Atlanta, GA): 4 new FDA device listings, incl. pin, fixation, smooth](/report/deviceestablishmentpulse/machining-midtown-llc-atlanta-ga--fdaest-3015709929-2026-09-17)
- [Medshape, Inc. (manufacturer, Atlanta, GA): 2 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/medshape-inc-atlanta-ga--fdaest-3007593722-2026-09-24)
- [O&M Halyard, Inc. (manufacturer, Alpharetta, GA): 11 new FDA device listings, incl. wrap, sterilization](/report/deviceestablishmentpulse/o-and-m-halyard-inc-alpharetta-ga--fdaest-3014421917-2026-07-27)
- [Panorthopaedics, Inc. (specification developer, Atlanta, GA): 3 new FDA device listings, incl. probe](/report/deviceestablishmentpulse/panorthopaedics-inc-atlanta-ga--fdaest-3023194129-2026-06-15)
- [Quipment Inc. (repackager or relabeler, Kennesaw, GA): 8 new FDA device listings, incl. set, administration, intravascular](/report/deviceestablishmentpulse/quipment-inc-kennesaw-ga--fdaest-3012302888-2026-08-25)
- [Sterigenics U.S., LLC (contract sterilizer, Atlanta, GA): 10 new FDA device listings, incl. prosthesis, ankle, semi-constrained, cemented, metal/polymer](/report/deviceestablishmentpulse/sterigenics-u-s-llc-atlanta-ga--fdaest-1018470-2026-06-04)
- [Strados Labs Inc. (specification developer, Marietta, GA): 2 new FDA device listings, incl. spirometer, diagnostic](/report/deviceestablishmentpulse/strados-labs-inc-marietta-ga--fdaest-3026042935-2026-10-05)
- [Sts Corporation (specification developer, Duluth, GA): 3 new FDA device listings, incl. anaerobic box glove](/report/deviceestablishmentpulse/sts-corporation-duluth-ga--fdaest-3014150341-2026-07-05)
- [Wise Linkers LLC (repackager or relabeler, Acworth, GA): 6 new FDA device listings, incl. cassettes, tissue](/report/deviceestablishmentpulse/wise-linkers-llc-acworth-ga--fdaest-3014829979-2026-07-07)

## Hawaii

- [Pacific Instruments Inc. (contract manufacturer, Honolulu, HI): 2 new FDA device listings, incl. sacroiliac joint fixation](/report/deviceestablishmentpulse/pacific-instruments-inc-honolulu-hi--fdaest-3005641619-2026-10-15)

## HK

- [Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. (foreign exporter, Tsimshatsui, Kowloon, HK): 2 new FDA device listings, incl. computer, diagnostic, programmable](/report/deviceestablishmentpulse/amphenol-cable-and-interconnect-technologies-asia-pacific-tsimshatsui-kowloon-hk--fdaest-3013500228-2026-08-17)
- [Beurer Far East Ltd. (foreign exporter, Hong Kong SAR, HK): 12 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning](/report/deviceestablishmentpulse/beurer-far-east-ltd-hong-kong-sar-hk--fdaest-3012134907-2026-08-19)
- [Cbr Enterprise Limited (foreign exporter, Hong Kong, HK): 50 new FDA device listings, incl. sleeve, limb, compressible](/report/deviceestablishmentpulse/cbr-enterprise-limited-hong-kong-hk--fdaest-3013557562-2026-10-14)
- [Delta International Trade Asia Pacific Ltd. (foreign exporter, Kowloon, HK): 2 new FDA device listings, incl. pack, hot or cold, disposable](/report/deviceestablishmentpulse/delta-international-trade-asia-pacific-ltd-kowloon-hk--fdaest-3009526336-2026-09-15)
- [Digital Dental Depot Limited (manufacturer, Hong Kong, HK): 5 new FDA device listings, incl. device, jaw repositioning](/report/deviceestablishmentpulse/digital-dental-depot-limited-hong-kong-hk--fdaest-3012341864-2026-08-06)
- [Duplex International Trading Limited (manufacturer, Hong Kong, HK): 2 new FDA device listings, incl. over-the-counter powered light based laser for acne](/report/deviceestablishmentpulse/duplex-international-trading-limited-hong-kong-hk--fdaest-3010360273-2026-09-11)
- [Healthcare Technology International Ltd. (foreign exporter, Shek Mun, Shatin, HK): 3 new FDA device listings, incl. instrument, surgical, orthopedic, ac-powered motor and accessory/attac](/report/deviceestablishmentpulse/healthcare-technology-international-ltd-shek-mun-shatin-hk--fdaest-3008959444-2026-05-12)
- [Hong Kong Lanli Technology Co., Limited (repackager or relabeler, Tuen Mun, HK): 2 new FDA device listings, incl. nebulizer (direct patient interface)](/report/deviceestablishmentpulse/hong-kong-lanli-technology-co-limited-tuen-mun-hk--fdaest-3034397208-2026-09-11)
- [Just Eyewear (Mfg) Co. Limited (manufacturer, Hong Kong, HK): 4 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)](/report/deviceestablishmentpulse/just-eyewear-mfg-co-limited-hong-kong-hk--fdaest-3045857232-2026-05-15)
- [Merit Medical Asia Company Limited (foreign exporter, Tsim Sha Tsui, HK): 6 new FDA device listings, incl. catheter, embolectomy](/report/deviceestablishmentpulse/merit-medical-asia-company-limited-tsim-sha-tsui-hk--fdaest-3015225571-2026-08-20)
- [Nu-Tek Health (Hongkong) Limited (foreign exporter, Kowloon Bay, HK): 9 new FDA device listings, incl. interferential current therapy](/report/deviceestablishmentpulse/nu-tek-health-hongkong-limited-kowloon-bay-hk--fdaest-3049809930-2026-08-17)
- [Soher Med Limited (foreign exporter, Hong Kong, HK): 257 new FDA device listings, incl. resin, denture, relining, repairing, rebasing](/report/deviceestablishmentpulse/soher-med-limited-hong-kong-hk--fdaest-3045857207-2026-10-10)
- [UAN Healthcare Limited (foreign exporter, Central, HK): 5 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter](/report/deviceestablishmentpulse/uan-healthcare-limited-central-hk--fdaest-3043013796-2026-06-29)
- [Warrenslove(Hongkong)limited (manufacturer, Kowloon, HK): 4 new FDA device listings, incl. lamp, infrared, therapeutic heating](/report/deviceestablishmentpulse/warrenslove-hongkong-limited-kowloon-hk--fdaest-3033530347-2026-09-25)
- [World Dentists Association America Limited (manufacturer, Tsim Sha, HK): 2 new FDA device listings, incl. irrigator, powered nasal](/report/deviceestablishmentpulse/world-dentists-association-america-limited-tsim-sha-hk--fdaest-3034048670-2026-08-17)
- [Worldwide Supplies Limited (foreign exporter, Hong Kong, HK): 117 new FDA device listings, incl. blood pressure cuff](/report/deviceestablishmentpulse/worldwide-supplies-limited-hong-kong-hk--fdaest-3014579161-2026-10-16)
- [Yizur Ltd (repackager or relabeler, Hong Kong, HK): 101 new FDA device listings, incl. applicator, absorbent tipped, non-sterile](/report/deviceestablishmentpulse/yizur-ltd-hong-kong-hk--fdaest-3045855232-2026-10-07)

## Idaho

- [H & H Co. (repackager or relabeler, Hayden, ID): 3 new FDA device listings, incl. handpiece, direct drive, ac-powered](/report/deviceestablishmentpulse/h-and-h-co-hayden-id--fdaest-2085199-2026-08-11)

## IE

- [Aps Materials Inc. Ireland (contract manufacturer, Waterford Waterford(County), IE): 8 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer + additive, ceme](/report/deviceestablishmentpulse/aps-materials-inc-ireland-waterford-waterford-county-ie--fdaest-3007740680-2026-06-08)
- [Boston Scientific Limited (manufacturer, CORK Munster, IE): 4 new FDA device listings, incl. hydrogel spacer](/report/deviceestablishmentpulse/boston-scientific-limited-cork-munster-ie--fdaest-9616684-2026-10-16)
- [Boston Scientific Limited (manufacturer, GALWAY Galway(County), IE): 5 new FDA device listings, incl. unit, electrosurgical, endoscopic (with or without accessories)](/report/deviceestablishmentpulse/boston-scientific-limited-galway-galway-county-ie--fdaest-9681260-2026-10-16)
- [Depuy (Ireland) (manufacturer, CO. CORK Munster, IE): 5 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented](/report/deviceestablishmentpulse/depuy-ireland-co-cork-munster-ie--fdaest-9616671-2026-08-07)
- [Dexcom International Limited (foreign exporter, Athenry Galway(County), IE): 5 new FDA device listings, incl. integrated continuous glucose monitor for non-intensive glucose manage](/report/deviceestablishmentpulse/dexcom-international-limited-athenry-galway-county-ie--fdaest-3037326582-2026-08-10)
- [EPIC MedTec OEM Ireland Limited (contract manufacturer, ANNACOTTY Limerick(County), IE): 12 new FDA device listings, incl. catheter, intravascular, diagnostic](/report/deviceestablishmentpulse/epic-medtec-oem-ireland-limited-annacotty-limerick-county-ie--fdaest-9616683-2026-08-20)
- [Merit Medical Ireland, Ltd (contract manufacturer, Galway Galway(County), IE): 5 new FDA device listings, incl. wire, guide, catheter](/report/deviceestablishmentpulse/merit-medical-ireland-ltd-galway-galway-county-ie--fdaest-9616662-2026-08-20)
- [Signature Orthopaedics Europe Ltd (manufacturer, Athlone Westmeath, IE): 4 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer](/report/deviceestablishmentpulse/signature-orthopaedics-europe-ltd-athlone-westmeath-ie--fdaest-3014763043-2026-06-01)
- [Stryker Ireland Ltd. Instruments Division, Innovation Centre (specification developer, Carrigtwohill Cork(County), IE): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/stryker-ireland-ltd-instruments-division-innovation-centre-carrigtwohill-cork-county-ie--fdaest-3040335671-2026-10-09)
- [Synergy Health Ireland Ltd (contract sterilizer, Tullamore Offaly, IE): 5 new FDA device listings, incl. instrument, ultrasonic surgical](/report/deviceestablishmentpulse/synergy-health-ireland-ltd-tullamore-offaly-ie--fdaest-3002807314-2026-10-14)
- [Synergy Health Westport Ltd (contract sterilizer, Westport Mayo, IE): 13 new FDA device listings, incl. hydrogel spacer](/report/deviceestablishmentpulse/synergy-health-westport-ltd-westport-mayo-ie--fdaest-3010173425-2026-10-14)

## Illinois

- [Alma Lasers Ltd. (manufacturer, CAESAREA Northern, IL): 5 new FDA device listings, incl. light based over the counter wrinkle reduction](/report/deviceestablishmentpulse/alma-lasers-ltd-caesarea-northern-il--fdaest-3004167969-2026-06-08)
- [Boka, LLC (repackager or relabeler, Chicago, IL): 4 new FDA device listings, incl. scraper, tongue](/report/deviceestablishmentpulse/boka-llc-chicago-il--fdaest-3044174138-2026-08-12)
- [Cardinal Health 200, LLC (other, Waukegan, IL): 8 new FDA device listings, incl. fentanyl and other opioid protection glove](/report/deviceestablishmentpulse/cardinal-health-200-llc-waukegan-il--fdaest-1423537-2026-10-13)
- [Donson Machine Company (contract manufacturer, Alsip, IL): 13 new FDA device listings, incl. wrench](/report/deviceestablishmentpulse/donson-machine-company-alsip-il--fdaest-3004153896-2026-08-11)
- [Gardner Medical Instruments, LLC (specification developer, Frankfort, IL): 2 new FDA device listings, incl. airway, oropharyngeal, anesthesiology](/report/deviceestablishmentpulse/gardner-medical-instruments-llc-frankfort-il--fdaest-3048721571-2026-09-01)
- [GE Medical Systems, Israel Ltd. (specification developer, Haifa, IL): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/ge-medical-systems-israel-ltd-haifa-il--fdaest-9615849-2026-08-10)
- [Gi View Ltd. (manufacturer, Ramat Gan Central, IL): 2 new FDA device listings, incl. colonoscope and accessories, flexible/rigid](/report/deviceestablishmentpulse/gi-view-ltd-ramat-gan-central-il--fdaest-3010229237-2026-08-23)
- [Icu Medical, Inc. (specification developer, Lake Forest, IL): 45 new FDA device listings, incl. pump, infusion](/report/deviceestablishmentpulse/icu-medical-inc-lake-forest-il--fdaest-3013319212-2026-07-21)
- [Isomedix Operations, Inc. (contract sterilizer, Libertyville, IL): 124 new FDA device listings, incl. starter, bone screw](/report/deviceestablishmentpulse/isomedix-operations-inc-libertyville-il--fdaest-1450662-2026-10-14)
- [Isomedix Operations, Inc. (contract sterilizer, Libertyville, IL): 7 new FDA device listings, incl. wound dressing with animal-derived material(s)](/report/deviceestablishmentpulse/isomedix-operations-inc-libertyville-il--fdaest-1424263-2026-10-15)
- [Labsource, Inc (specification developer, Northlake, IL): 7 new FDA device listings, incl. polymer patient examination glove](/report/deviceestablishmentpulse/labsource-inc-northlake-il--fdaest-3012429634-2026-10-13)
- [Mastel Surgical Inc. (contract manufacturer, Schiller Park, IL): 4 new FDA device listings, incl. nebulizer, medicinal, non-ventilatory (atomizer)](/report/deviceestablishmentpulse/mastel-surgical-inc-schiller-park-il--fdaest-3042624965-2026-09-24)
- [Maya Medical Top Trade Ltd. (foreign exporter, Tsofit Central, IL): 22 new FDA device listings, incl. culture media, non-propagating transport](/report/deviceestablishmentpulse/maya-medical-top-trade-ltd-tsofit-central-il--fdaest-3036773433-2026-08-14)
- [Medgyn Products, Inc. (manufacturer, Westmont, IL): 2 new FDA device listings, incl. electrocautery, gynecologic (and accessories)](/report/deviceestablishmentpulse/medgyn-products-inc-westmont-il--fdaest-1450908-2026-08-14)
- [MEDLINE INDUSTRIES, LP - Northfield (specification developer, Northfield, IL): 144 new FDA device listings, incl. wrap, sterilization](/report/deviceestablishmentpulse/medline-industries-lp-northfield-northfield-il--fdaest-1417592-2026-10-08)
- [Medline Industries, LP - Spt (manufacturer, Waukegan, IL): 7 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/medline-industries-lp-spt-waukegan-il--fdaest-1423395-2026-06-05)
- [MEDLINE INDUSTRIES, LP (Northpoint Services) (contract sterilizer, Waukegan, IL): 11 new FDA device listings, incl. enteral syringes with enteral specific connectors](/report/deviceestablishmentpulse/medline-industries-lp-northpoint-services-waukegan-il--fdaest-1422634-2026-06-04)
- [Nuvomed Inc (repackager or relabeler, Broadview, IL): 5 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive](/report/deviceestablishmentpulse/nuvomed-inc-broadview-il--fdaest-3014449259-2026-08-18)
- [Omron Healthcare, Inc. (repackager or relabeler, Hoffman Est, IL): 2 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive](/report/deviceestablishmentpulse/omron-healthcare-inc-hoffman-est-il--fdaest-1450057-2026-09-11)
- [Ontogen Manufacturing LLC (contract manufacturer, Lisle, IL): 5 new FDA device listings, incl. adaptor, ureteral catheter](/report/deviceestablishmentpulse/ontogen-manufacturing-llc-lisle-il--fdaest-3038472982-2026-08-31)
- [Philips Medical Systems Technologies Ltd. (manufacturer, Haifa, IL): 4 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/philips-medical-systems-technologies-ltd-haifa-il--fdaest-3015763655-2026-08-17)
- [Prime Dental Manufacturing, Inc. (manufacturer, Chicago, IL): 2 new FDA device listings, incl. applicator, resin](/report/deviceestablishmentpulse/prime-dental-manufacturing-inc-chicago-il--fdaest-1424442-2026-08-19)
- [R.H. Electronics Ltd. (contract manufacturer, Nof Hagalil Northern, IL): 6 new FDA device listings, incl. over-the-counter radiofrequency coagulation device for wrinkle reducti](/report/deviceestablishmentpulse/r-h-electronics-ltd-nof-hagalil-northern-il--fdaest-3005238200-2026-07-07)
- [Rapid-Medical Ltd (manufacturer, yokneam Northern, IL): 4 new FDA device listings, incl. catheter, thrombus retriever](/report/deviceestablishmentpulse/rapid-medical-ltd-yokneam-northern-il--fdaest-3009957947-2026-09-20)
- [Siemens Medical Solutions USA, Inc. (contract manufacturer, Hoffman Estates, IL): 5 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/siemens-medical-solutions-usa-inc-hoffman-estates-il--fdaest-1423253-2026-07-07)
- [Sol-Millennium Medical, Inc. (specification developer, Chicago, IL): 8 new FDA device listings, incl. bandage, elastic](/report/deviceestablishmentpulse/sol-millennium-medical-inc-chicago-il--fdaest-3014312726-2026-09-28)
- [Sor Van Radiation Ltd (contract sterilizer, Yavne Tel Aviv, IL): 6 new FDA device listings, incl. implant, endosseous, root-form](/report/deviceestablishmentpulse/sor-van-radiation-ltd-yavne-tel-aviv-il--fdaest-3002808227-2026-05-23)
- [Spinecraft LLC (manufacturer, Westmont, IL): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/spinecraft-llc-westmont-il--fdaest-3004717358-2026-05-12)
- [Sterigenics U.S., LLC (contract sterilizer, Schaumburg, IL): 7 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/sterigenics-u-s-llc-schaumburg-il--fdaest-1420032-2026-06-25)
- [Sterigenics US LLC (contract sterilizer, Gurnee, IL): 19 new FDA device listings, incl. lipoaspirate washing system for aesthetic body contouring](/report/deviceestablishmentpulse/sterigenics-us-llc-gurnee-il--fdaest-1423662-2026-07-09)
- [SUNSET HEALTHCARE SOLUTIONS, Inc. (repackager or relabeler, Chicago, IL): 3 new FDA device listings, incl. device, positive pressure breathing, intermittent](/report/deviceestablishmentpulse/sunset-healthcare-solutions-inc-chicago-il--fdaest-3006446479-2026-09-01)
- [TEMPUS AI, Inc. (manufacturer, Chicago, IL): 2 new FDA device listings, incl. pulmonary hypertension machine learning-based notification software](/report/deviceestablishmentpulse/tempus-ai-inc-chicago-il--fdaest-3013200421-2026-09-03)
- [Usr Electronic Systems (1987) Ltd (contract manufacturer, Karmiel Northern, IL): 3 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning](/report/deviceestablishmentpulse/usr-electronic-systems-1987-ltd-karmiel-northern-il--fdaest-3006807694-2026-07-28)
- [Venus Concept Ltd. (foreign exporter, Yokneam Illit Northern, IL): 3 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/venus-concept-ltd-yokneam-illit-northern-il--fdaest-3008915316-2026-07-06)
- [Veridian Healthcare LLC (repackager or relabeler, Gurnee, IL): 4 new FDA device listings, incl. clinical electronic thermometer](/report/deviceestablishmentpulse/veridian-healthcare-llc-gurnee-il--fdaest-3045528409-2026-08-19)
- [Vomark Technologies Inc (repackager or relabeler, Wheeling, IL): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic](/report/deviceestablishmentpulse/vomark-technologies-inc-wheeling-il--fdaest-3014639846-2026-05-06)
- [Wondfo USA Co., Ltd. (other, Bolingbrook, IL): 11 new FDA device listings, incl. enzyme immunoassay, phencyclidine](/report/deviceestablishmentpulse/wondfo-usa-co-ltd-bolingbrook-il--fdaest-3007606081-2026-08-05)

## Indiana

- [Accuster Technologies Pvt. Ltd. (manufacturer, New Delhi, IN): 7 new FDA device listings, incl. slides, microscope](/report/deviceestablishmentpulse/accuster-technologies-pvt-ltd-new-delhi-in--fdaest-3048141116-2026-06-12)
- [Apothecaries Sundries Mfg Pvt Ltd (manufacturer, GURUGRAM Haryana, IN): 26 new FDA device listings, incl. shoe, cast](/report/deviceestablishmentpulse/apothecaries-sundries-mfg-pvt-ltd-gurugram-haryana-in--fdaest-3007123908-2026-06-25)
- [Arcamed, LLC (contract manufacturer, Indianapolis, IN): 5 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/arcamed-llc-indianapolis-in--fdaest-3010622588-2026-05-19)
- [Arck Technologies Innovations Pvt Ltd (manufacturer, Vasai Maharashtra, IN): 4 new FDA device listings, incl. labware, assisted reproduction, exempt](/report/deviceestablishmentpulse/arck-technologies-innovations-pvt-ltd-vasai-maharashtra-in--fdaest-3045853418-2026-05-18)
- [Baxter Innovations & Business Solutions Pvt. Ltd. (specification developer, Bangalore Karnataka, IN): 4 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/baxter-innovations-and-business-solutions-pvt-ltd-bangalore-karnataka-in--fdaest-3015158050-2026-08-20)
- [Biomet, Inc. (manufacturer, Warsaw, IN): 18 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented](/report/deviceestablishmentpulse/biomet-inc-warsaw-in--fdaest-1825034-2026-09-24)
- [Boston Scientific Corporation (manufacturer, Spencer, IN): 6 new FDA device listings, incl. kit, nephroscope](/report/deviceestablishmentpulse/boston-scientific-corporation-spencer-in--fdaest-1828132-2026-09-21)
- [Chlorophyllic Concepts (Opc) Private Limited (contract manufacturer, Thane Maharashtra, IN): 12 new FDA device listings, incl. shoulder prosthesis, reverse configuration](/report/deviceestablishmentpulse/chlorophyllic-concepts-opc-private-limited-thane-maharashtra-in--fdaest-3048515471-2026-09-01)
- [Cook Medical LLC (contract manufacturer, Bloomington, IN): 4 new FDA device listings, incl. tube, tracheal (w/wo connector)](/report/deviceestablishmentpulse/cook-medical-llc-bloomington-in--fdaest-3005580113-2026-10-13)
- [Depuy Orthopaedics, Inc. (manufacturer, Warsaw, IN): 12 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented](/report/deviceestablishmentpulse/depuy-orthopaedics-inc-warsaw-in--fdaest-1818910-2026-08-07)
- [Dot America, Inc. (contract manufacturer, Columbia City, IN): 5 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer](/report/deviceestablishmentpulse/dot-america-inc-columbia-city-in--fdaest-3011461101-2026-08-05)
- [G & H Wire Company (repackager or relabeler, Franklin, IN): 2 new FDA device listings, incl. bracket, ceramic, orthodontic](/report/deviceestablishmentpulse/g-and-h-wire-company-franklin-in--fdaest-1833132-2026-09-15)
- [Hill-Rom, Inc. (manufacturer, Batesville, IN): 3 new FDA device listings, incl. monitor, breathing frequency](/report/deviceestablishmentpulse/hill-rom-inc-batesville-in--fdaest-1824206-2026-08-20)
- [Intersurgical Inc. (repackager or relabeler, Indianapolis, IN): 2 new FDA device listings, incl. clip, nose](/report/deviceestablishmentpulse/intersurgical-inc-indianapolis-in--fdaest-1832562-2026-10-09)
- [Kamal Encon Industries Limited (manufacturer, Faridabad Haryana, IN): 7 new FDA device listings, incl. dentures, full](/report/deviceestablishmentpulse/kamal-encon-industries-limited-faridabad-haryana-in--fdaest-3019677226-2026-07-11)
- [Kimball Solutions Jasper, Inc. (contract manufacturer, Jasper, IN): 9 new FDA device listings, incl. interventional fluoroscopic x-ray system](/report/deviceestablishmentpulse/kimball-solutions-jasper-inc-jasper-in--fdaest-3008253300-2026-07-20)
- [Labotech Microscopes India Private Limited (manufacturer, AMBALA CANTT Haryana, IN): 2 new FDA device listings, incl. colposcope (and colpomicroscope), exempt](/report/deviceestablishmentpulse/labotech-microscopes-india-private-limited-ambala-cantt-haryana-in--fdaest-3005527296-2026-08-27)
- [Laparomed Private Limited (manufacturer, Mumbai Maharashtra, IN): 51 new FDA device listings, incl. probe, periodontic](/report/deviceestablishmentpulse/laparomed-private-limited-mumbai-maharashtra-in--fdaest-3045853999-2026-05-05)
- [LifeSignals India Private Limited (contract manufacturer, Bangalore Karnataka, IN): 4 new FDA device listings, incl. outpatient cardiac telemetry](/report/deviceestablishmentpulse/lifesignals-india-private-limited-bangalore-karnataka-in--fdaest-3017446092-2026-07-17)
- [Lifewear Technologies India Private Limited (manufacturer, Solan Himachal Pradesh, IN): 8 new FDA device listings, incl. splint, hand, and components](/report/deviceestablishmentpulse/lifewear-technologies-india-private-limited-solan-himachal-pradesh-in--fdaest-3045853560-2026-06-05)
- [Lords Mark Industries Ltd. (manufacturer, Daman and Diu Dadra and Nagar Haveli, IN): 50 new FDA device listings, incl. electrode, ion selective (non-specified)](/report/deviceestablishmentpulse/lords-mark-industries-ltd-daman-and-diu-dadra-and-nagar--in--fdaest-3039396083-2026-09-30)
- [Medart Technology Private Limited (contract manufacturer, Valsad Gujarat, IN): 3 new FDA device listings, incl. bit, drill](/report/deviceestablishmentpulse/medart-technology-private-limited-valsad-gujarat-in--fdaest-3042226236-2026-07-14)
- [Medartis Inc. (specification developer, Warsaw, IN): 2 new FDA device listings, incl. prosthesis, elbow, hemi-, radial, polymer](/report/deviceestablishmentpulse/medartis-inc-warsaw-in--fdaest-3009540749-2026-10-12)
- [Micropulse Inc (contract manufacturer, Columbia City, IN): 45 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar](/report/deviceestablishmentpulse/micropulse-inc-columbia-city-in--fdaest-1834379-2026-08-20)
- [NGInstruments, Inc dba Avalign Cutting Instruments (contract manufacturer, Warsaw, IN): 4 new FDA device listings, incl. instrument, surgical, orthopedic, ac-powered motor and accessory/attac](/report/deviceestablishmentpulse/nginstruments-inc-dba-avalign-cutting-instruments-warsaw-in--fdaest-1835251-2026-10-16)
- [Orthopediatrics, Corp (specification developer, Warsaw, IN): 5 new FDA device listings, incl. file](/report/deviceestablishmentpulse/orthopediatrics-corp-warsaw-in--fdaest-3006460162-2026-09-28)
- [Philips India Limited - Image Guided Therapy Systems Business Unit (contract manufacturer, Bengaluru Karnataka, IN): 6 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/philips-india-limited-image-guided-therapy-systems-business-bengaluru-karnataka-in--fdaest-3033527282-2026-08-13)
- [Philips India Limited - Image Guided Therapy Systems Business Unit (specification developer, Pune Maharashtra, IN): 3 new FDA device listings, incl. interventional fluoroscopic x-ray system](/report/deviceestablishmentpulse/philips-india-limited-image-guided-therapy-systems-business-pune-maharashtra-in--fdaest-3033525987-2026-08-13)
- [Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units (specification developer, Bengaluru Karnataka, IN): 4 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/philips-india-limited-radiology-informatics-clinical-bengaluru-karnataka-in--fdaest-3033527273-2026-08-17)
- [Poly Medicure Ltd. (manufacturer, Faridabad Haryana, IN): 3 new FDA device listings, incl. catheter, intravascular, therapeutic, short-term less than 30 days](/report/deviceestablishmentpulse/poly-medicure-ltd-faridabad-haryana-in--fdaest-9616991-2026-09-29)
- [Power Dental Studio Milling Pvt Ltd (manufacturer, Noida Uttar Pradesh, IN): 2 new FDA device listings, incl. alloy, metal, base](/report/deviceestablishmentpulse/power-dental-studio-milling-pvt-ltd-noida-uttar-pradesh-in--fdaest-3031087017-2026-08-27)
- [Siemens Healthcare Pvt. Ltd. (contract manufacturer, Bangalore, IN): 3 new FDA device listings, incl. system, nuclear magnetic resonance imaging](/report/deviceestablishmentpulse/siemens-healthcare-pvt-ltd-bangalore-in--fdaest-3025602463-2026-08-03)
- [Steel City Health Private Limited (repackager or relabeler, Gurugram Haryana, IN): 2 new FDA device listings, incl. material, impression tray, resin](/report/deviceestablishmentpulse/steel-city-health-private-limited-gurugram-haryana-in--fdaest-3027315856-2026-09-02)
- [Sterigenics Radiation Technologies IN, Inc (contract sterilizer, Columbia City, IN): 3 new FDA device listings, incl. sacroiliac joint fixation](/report/deviceestablishmentpulse/sterigenics-radiation-technologies-in-inc-columbia-city-in--fdaest-3009504230-2026-06-04)
- [Viant AS&O Holdings, LLC (contract manufacturer, Indianapolis, IN): 4 new FDA device listings, incl. sterilization wrap containers, trays, cassettes & other accessories](/report/deviceestablishmentpulse/viant-as-and-o-holdings-llc-indianapolis-in--fdaest-1832228-2026-08-19)
- [Wipro GE Healthcare Private Ltd. (manufacturer, Bangalore Karnataka, IN): 19 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/wipro-ge-healthcare-private-ltd-bangalore-karnataka-in--fdaest-9617277-2026-10-07)
- [Wipro Ge Medical Device Manufacturing Private Limited (manufacturer, Bangalore Karnataka, IN): 19 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic](/report/deviceestablishmentpulse/wipro-ge-medical-device-manufacturing-private-limited-bangalore-karnataka-in--fdaest-3032109181-2026-10-07)

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