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).

Delaware

• Karl Storz Se & Co. Kg (contract manufacturer, TUTTLINGEN Baden-Wurttemberg, DE): 6 new FDA device listings, incl. hysteroscope (and accessories)
• Kettenbach GmbH & Co Kg (manufacturer, ESCHENBURG Hesse, DE): 2 new FDA device listings, incl. agent, polishing, abrasive, oral cavity
• Leraise Health International LLC (other, Dover, DE): 3 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• 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
• Nessa Global Inc. (specification developer, Dover, DE): 2 new FDA device listings, incl. lipoaspirate washing system for aesthetic body contouring
• Rhenus Se & Co. Kg (foreign exporter, Holzwickede North Rhine-Westphalia, DE): 11 new FDA device listings, incl. introducer, catheter
• Siemens Healthcare Diagnostics Inc. (manufacturer, Newark, DE): 3 new FDA device listings, incl. bilirubin (total and unbound) in the neonate test system
• Stryker Leibinger GmbH & Co. Kg (manufacturer, FREIBURG Baden-Wurttemberg, DE): 5 new FDA device listings, incl. drill, bone, powered
• Titanlinks Logistics LLC (repackager or relabeler, Newark, DE): 336 new FDA device listings, incl. scaler, ultrasonic
• 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

DO

• STERIS Corporation de Republica Dominicana, S.R.L. (contract sterilizer, Santo Domingo, DO): 3 new FDA device listings, incl. system, x-ray, mammographic

ES

• B.T.I. Biotechnology Institute, S.L. (foreign exporter, Miñano Alava, ES): 3 new FDA device listings, incl. syringe, antistick

Florida

• Advance-Esthetic LLC (other, Fort Lauderdale, FL): 8 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Apyx Medical Corporation (manufacturer, Clearwater, FL): 2 new FDA device listings, incl. system, suction, lipoplasty for removal
• Arthrex, Inc. (contract manufacturer, Ave Maria, FL): 10 new FDA device listings, incl. screw, fixation, bone
• Arthrex, Inc. (specification developer, Naples, FL): 12 new FDA device listings, incl. screw, fixation, bone
• Aso LLC (other, Sarasota, FL): 3 new FDA device listings, incl. dressing, wound, drug
• Aurora Dermo Corp (repackager or relabeler, Miami, FL): 9 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Cerenovus, Inc. (manufacturer, Miami, FL): 5 new FDA device listings, incl. device, neurovascular embolization
• CQ Decimal, LLC (manufacturer, Sanford, FL): 14 new FDA device listings, incl. block, beam-shaping, radiation therapy
• EmCyte Corporation (specification developer, Fort Myers, FL): 2 new FDA device listings, incl. powered microneedle device
• Exactech, Inc. (manufacturer, Gainesville, FL): 5 new FDA device listings, incl. prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-po
• First Nation Group, LLC (specification developer, Saint Petersburg, FL): 2 new FDA device listings, incl. mattress, flotation therapy, non-powered
• Forsure Medical Products LLC. (repackager or relabeler, Doral, FL): 10 new FDA device listings, incl. tube, tracheostomy (w/wo connector)
• Gfa Production Inc (specification developer, Clearwater, FL): 25 new FDA device listings, incl. finger cot
• Glownar Aesthetics. LLC (specification developer, Davie, FL): 10 new FDA device listings, incl. brush, dermabrasion, powered
• Hc Biologics LLC (manufacturer, Miami, FL): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, cervical
• Headsafe US INC (other, Lake Mary, FL): 2 new FDA device listings, incl. reduced- montage standard electroencephalograph
• Iradimed Corporation (manufacturer, Orlando, FL): 3 new FDA device listings, incl. set, i.v. fluid transfer
• Merits Health Products., Inc. (repackager or relabeler, Fort Myers, FL): 5 new FDA device listings, incl. powered stairway chair lift
• Metier Medical (USA) LLC (other, Ponte Vedra Beach, FL): 7 new FDA device listings, incl. needle, aspiration and injection, disposable
• Oketz Logistics LLC (repackager or relabeler, Coral Gables, FL): 56 new FDA device listings, incl. sterilization wrap containers, trays, cassettes & other accessories
• Ortho Max Inc (other, Palm City, FL): 14 new FDA device listings, incl. orthopedic manual surgical instrument
• Osteomni Inc (specification developer, Miami, FL): 5 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical
• Prabadin Corp (other, Miami, FL): 23 new FDA device listings, incl. visual, pregnancy hcg, prescription use
• Sentinel Medical Technologies, LLC (manufacturer, Jacksonville, FL): 2 new FDA device listings, incl. intra-abdominal pressure monitoring device
• Shapes Secrets LLC (repackager or relabeler, Doral, FL): 5 new FDA device listings, incl. bedding, disposable, medical
• Stellmacher Instruments Inc (repackager or relabeler, Orlando, FL): 30 new FDA device listings, incl. handle, scalpel
• Strauss Surgical USA LLC. (repackager or relabeler, Doral, FL): 2 new FDA device listings, incl. endoscopic grasping/cutting instrument, non-powered, exempt
• Structure Medical, LLC. (contract manufacturer, Naples, FL): 27 new FDA device listings, incl. appliance, fixation, spinal interlaminal
• Summit Orthopedic Technologies Inc. (contract manufacturer, Naples, FL): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar
• Surgentec LLC (manufacturer, Boca Raton, FL): 15 new FDA device listings, incl. system, facet screw spinal device
• Surgipros LLC (repackager or relabeler, Palmetto, FL): 29 new FDA device listings, incl. elevator, ent
• Toyo Medical Co. (repackager or relabeler, Doral, FL): 2 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• VIVE Health LLC (repackager or relabeler, Naples, FL): 10 new FDA device listings, incl. wheelchair, powered
• Zapalign LLC (repackager or relabeler, Fort Lauderdale, FL): 54 new FDA device listings, incl. mask, gas, anesthetic
• ZimVie US Corp LLC (contract manufacturer, Palm Beach Gardens, FL): 5 new FDA device listings, incl. abutment, implant, dental, endosseous

GB

• Ad Supply Group Limited (foreign exporter, London London, City of, GB): 39 new FDA device listings, incl. drills, burrs, trephines & accessories (simple, powered)
• Andersen Caledonia Ltd (contract sterilizer, Bellshill Scotland, GB): 4 new FDA device listings, incl. protector, ostomy
• Bioliberty Ltd (specification developer, Edinburgh Edinburgh, City of, GB): 2 new FDA device listings, incl. interactive rehabilitation exercise device, prescription use
• Cme Devices Ltd (contract manufacturer, CHEPSTOW Monmouthshire, GB): 9 new FDA device listings, incl. system, ablation, microwave and accessories
• Corin Limited (manufacturer, CIRENCESTER Gloucestershire, GB): 5 new FDA device listings, incl. prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
• Current Health Ltd (specification developer, Edinburgh Edinburgh, City of, GB): 6 new FDA device listings, incl. spirometer, diagnostic
• Depuy Intl., Ltd. (manufacturer, Leeds, GB): 4 new FDA device listings, incl. bone cement
• Digital Surgery Limited (manufacturer, London London, City of, GB): 2 new FDA device listings, incl. software controlled endoscope and instrument holder
• Flexicare Medical Ltd. (specification developer, RHONDDA CYNON TAFF Wales, GB): 2 new FDA device listings, incl. cart, emergency, cardiopulmonary (excluding equipment)
• Immunodiagnostic Systems Ltd. (manufacturer, Boldon Colliery Durham, GB): 4 new FDA device listings, incl. extractable antinuclear antibody, antigen and control
• Loudwater Trade Finance Ltd (foreign exporter, LONDON England, GB): 3 new FDA device listings, incl. tube, tracheostomy (w/wo connector)
• Mast Group Ltd. (manufacturer, BOOTLE, MERSEYSIDE Liverpool, GB): 3 new FDA device listings, incl. susceptibility test discs, antimicrobial
• Merit Medical UK Limited (foreign exporter, Earley Reading, GB): 6 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization
• Odin Medical Limited (manufacturer, London London, City of, GB): 2 new FDA device listings, incl. gastrointesinal lesion software detection system
• Optikal (Southgate) Ltd (foreign exporter, Borehamwood, GB): 3 new FDA device listings, incl. lenses, soft contact, extended wear
• Pilson Direct Trading Limited (foreign exporter, Newcastle Newcastle upon Tyne, GB): 11 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic
• Platinum Focus Group Ltd. (foreign exporter, London London, City of, GB): 16 new FDA device listings, incl. orthosis, lumbo-sacral
• Probo Medical Ltd (foreign exporter, Gloucester Gloucestershire, GB): 19 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology
• Purebrand Slutions Ltd (foreign exporter, London England, GB): 71 new FDA device listings, incl. insufflator, laparoscopic
• 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
• Spectrum Medical Ltd (manufacturer, GLOUCESTER Gloucestershire, GB): 3 new FDA device listings, incl. control, pump speed, cardiopulmonary bypass
• Sterigenics Uk Limited (contract sterilizer, Chesterfield Derbyshire, GB): 3 new FDA device listings, incl. filler, bone void, calcium compound
• Summit Medical Ltd. (foreign exporter, Gloucestershire, GB): 2 new FDA device listings, incl. instrument, surgical, orthopedic, pneumatic powered & accessory/attach
• 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
• Synergy Health Sterilisation Uk Ltd (contract sterilizer, Daventry Northamptonshire, GB): 4 new FDA device listings, incl. orthopedic tray
• Synergy Health Sterilisation UK Ltd (contract sterilizer, Thorne Doncaster, GB): 4 new FDA device listings, incl. barrier, animal source, intraoral
• 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
• Systagenix Wound Management Manufacturing Limited (contract manufacturer, North Yorkshire, GB): 7 new FDA device listings, incl. sterilant, medical devices
• 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
• Veenak International Limited (foreign exporter, Birmingham, GB): 3 new FDA device listings, incl. spirometer, diagnostic
• Venture Healthcare Ltd (foreign exporter, London London, City of, GB): 2 new FDA device listings, incl. dressing, wound, drug
• Xiros Ltd (contract manufacturer, YEADON Leeds, GB): 3 new FDA device listings, incl. mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon

Georgia

• Boston Scientific Corporation (manufacturer, Roswell, GA): 5 new FDA device listings, incl. mesh, surgical, polymeric
• C.R. Bard, Inc. (contract sterilizer, Covington, GA): 11 new FDA device listings, incl. plethysmograph, impedance
• C.R. Bard, Inc. (contract sterilizer, Madison, GA): 10 new FDA device listings, incl. catheter, flow directed
• CHS USA Incorporated (specification developer, Peachtree City, GA): 2 new FDA device listings, incl. syringe, piston
• Dornier Medtech America, Inc. (other, Kennesaw, GA): 4 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid
• Drive Northpoint, LLC (manufacturer, Palmetto, GA): 26 new FDA device listings, incl. unit, filter, membrane
• Emsere, Inc. (repackager or relabeler, Peachtree City, GA): 11 new FDA device listings, incl. camera, ophthalmic, slit-scanning
• Hsg-S Corp (manufacturer, Savannah, GA): 20 new FDA device listings, incl. carrier, amalgam, operative
• Machining Midtown LLC (contract manufacturer, Atlanta, GA): 4 new FDA device listings, incl. pin, fixation, smooth
• Medshape, Inc. (manufacturer, Atlanta, GA): 2 new FDA device listings, incl. screw, fixation, bone
• O&M Halyard, Inc. (manufacturer, Alpharetta, GA): 11 new FDA device listings, incl. wrap, sterilization
• Panorthopaedics, Inc. (specification developer, Atlanta, GA): 3 new FDA device listings, incl. probe
• Quipment Inc. (repackager or relabeler, Kennesaw, GA): 8 new FDA device listings, incl. set, administration, intravascular
• Sterigenics U.S., LLC (contract sterilizer, Atlanta, GA): 10 new FDA device listings, incl. prosthesis, ankle, semi-constrained, cemented, metal/polymer
• Strados Labs Inc. (specification developer, Marietta, GA): 2 new FDA device listings, incl. spirometer, diagnostic
• Sts Corporation (specification developer, Duluth, GA): 3 new FDA device listings, incl. anaerobic box glove
• Wise Linkers LLC (repackager or relabeler, Acworth, GA): 6 new FDA device listings, incl. cassettes, tissue

Hawaii

• Pacific Instruments Inc. (contract manufacturer, Honolulu, HI): 2 new FDA device listings, incl. sacroiliac joint fixation

HK

• Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. (foreign exporter, Tsimshatsui, Kowloon, HK): 2 new FDA device listings, incl. computer, diagnostic, programmable
• Beurer Far East Ltd. (foreign exporter, Hong Kong SAR, HK): 12 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• Cbr Enterprise Limited (foreign exporter, Hong Kong, HK): 50 new FDA device listings, incl. sleeve, limb, compressible
• Delta International Trade Asia Pacific Ltd. (foreign exporter, Kowloon, HK): 2 new FDA device listings, incl. pack, hot or cold, disposable
• Digital Dental Depot Limited (manufacturer, Hong Kong, HK): 5 new FDA device listings, incl. device, jaw repositioning
• Duplex International Trading Limited (manufacturer, Hong Kong, HK): 2 new FDA device listings, incl. over-the-counter powered light based laser for acne
• 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
• Hong Kong Lanli Technology Co., Limited (repackager or relabeler, Tuen Mun, HK): 2 new FDA device listings, incl. nebulizer (direct patient interface)
• Just Eyewear (Mfg) Co. Limited (manufacturer, Hong Kong, HK): 4 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• Merit Medical Asia Company Limited (foreign exporter, Tsim Sha Tsui, HK): 6 new FDA device listings, incl. catheter, embolectomy
• Nu-Tek Health (Hongkong) Limited (foreign exporter, Kowloon Bay, HK): 9 new FDA device listings, incl. interferential current therapy
• Soher Med Limited (foreign exporter, Hong Kong, HK): 257 new FDA device listings, incl. resin, denture, relining, repairing, rebasing
• UAN Healthcare Limited (foreign exporter, Central, HK): 5 new FDA device listings, incl. stimulator, nerve, transcutaneous, over-the-counter
• Warrenslove(Hongkong)limited (manufacturer, Kowloon, HK): 4 new FDA device listings, incl. lamp, infrared, therapeutic heating
• World Dentists Association America Limited (manufacturer, Tsim Sha, HK): 2 new FDA device listings, incl. irrigator, powered nasal
• Worldwide Supplies Limited (foreign exporter, Hong Kong, HK): 117 new FDA device listings, incl. blood pressure cuff
• Yizur Ltd (repackager or relabeler, Hong Kong, HK): 101 new FDA device listings, incl. applicator, absorbent tipped, non-sterile

Idaho

• H & H Co. (repackager or relabeler, Hayden, ID): 3 new FDA device listings, incl. handpiece, direct drive, ac-powered

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
• Boston Scientific Limited (manufacturer, CORK Munster, IE): 4 new FDA device listings, incl. hydrogel spacer
• Boston Scientific Limited (manufacturer, GALWAY Galway(County), IE): 5 new FDA device listings, incl. unit, electrosurgical, endoscopic (with or without accessories)
• Depuy (Ireland) (manufacturer, CO. CORK Munster, IE): 5 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented
• Dexcom International Limited (foreign exporter, Athenry Galway(County), IE): 5 new FDA device listings, incl. integrated continuous glucose monitor for non-intensive glucose manage
• EPIC MedTec OEM Ireland Limited (contract manufacturer, ANNACOTTY Limerick(County), IE): 12 new FDA device listings, incl. catheter, intravascular, diagnostic
• Merit Medical Ireland, Ltd (contract manufacturer, Galway Galway(County), IE): 5 new FDA device listings, incl. wire, guide, catheter
• Signature Orthopaedics Europe Ltd (manufacturer, Athlone Westmeath, IE): 4 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer
• Stryker Ireland Ltd. Instruments Division, Innovation Centre (specification developer, Carrigtwohill Cork(County), IE): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Synergy Health Ireland Ltd (contract sterilizer, Tullamore Offaly, IE): 5 new FDA device listings, incl. instrument, ultrasonic surgical
• Synergy Health Westport Ltd (contract sterilizer, Westport Mayo, IE): 13 new FDA device listings, incl. hydrogel spacer

Illinois

• Alma Lasers Ltd. (manufacturer, CAESAREA Northern, IL): 5 new FDA device listings, incl. light based over the counter wrinkle reduction
• Boka, LLC (repackager or relabeler, Chicago, IL): 4 new FDA device listings, incl. scraper, tongue
• Cardinal Health 200, LLC (other, Waukegan, IL): 8 new FDA device listings, incl. fentanyl and other opioid protection glove
• Donson Machine Company (contract manufacturer, Alsip, IL): 13 new FDA device listings, incl. wrench
• Gardner Medical Instruments, LLC (specification developer, Frankfort, IL): 2 new FDA device listings, incl. airway, oropharyngeal, anesthesiology
• GE Medical Systems, Israel Ltd. (specification developer, Haifa, IL): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Gi View Ltd. (manufacturer, Ramat Gan Central, IL): 2 new FDA device listings, incl. colonoscope and accessories, flexible/rigid
• Icu Medical, Inc. (specification developer, Lake Forest, IL): 45 new FDA device listings, incl. pump, infusion
• Isomedix Operations, Inc. (contract sterilizer, Libertyville, IL): 124 new FDA device listings, incl. starter, bone screw
• Isomedix Operations, Inc. (contract sterilizer, Libertyville, IL): 7 new FDA device listings, incl. wound dressing with animal-derived material(s)
• Labsource, Inc (specification developer, Northlake, IL): 7 new FDA device listings, incl. polymer patient examination glove
• Mastel Surgical Inc. (contract manufacturer, Schiller Park, IL): 4 new FDA device listings, incl. nebulizer, medicinal, non-ventilatory (atomizer)
• Maya Medical Top Trade Ltd. (foreign exporter, Tsofit Central, IL): 22 new FDA device listings, incl. culture media, non-propagating transport
• Medgyn Products, Inc. (manufacturer, Westmont, IL): 2 new FDA device listings, incl. electrocautery, gynecologic (and accessories)
• MEDLINE INDUSTRIES, LP - Northfield (specification developer, Northfield, IL): 144 new FDA device listings, incl. wrap, sterilization
• Medline Industries, LP - Spt (manufacturer, Waukegan, IL): 7 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• MEDLINE INDUSTRIES, LP (Northpoint Services) (contract sterilizer, Waukegan, IL): 11 new FDA device listings, incl. enteral syringes with enteral specific connectors
• Nuvomed Inc (repackager or relabeler, Broadview, IL): 5 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• Omron Healthcare, Inc. (repackager or relabeler, Hoffman Est, IL): 2 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive
• Ontogen Manufacturing LLC (contract manufacturer, Lisle, IL): 5 new FDA device listings, incl. adaptor, ureteral catheter
• Philips Medical Systems Technologies Ltd. (manufacturer, Haifa, IL): 4 new FDA device listings, incl. system, x-ray, tomography, computed
• Prime Dental Manufacturing, Inc. (manufacturer, Chicago, IL): 2 new FDA device listings, incl. applicator, resin
• 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
• Rapid-Medical Ltd (manufacturer, yokneam Northern, IL): 4 new FDA device listings, incl. catheter, thrombus retriever
• Siemens Medical Solutions USA, Inc. (contract manufacturer, Hoffman Estates, IL): 5 new FDA device listings, incl. automated radiological image processing software
• Sol-Millennium Medical, Inc. (specification developer, Chicago, IL): 8 new FDA device listings, incl. bandage, elastic
• Sor Van Radiation Ltd (contract sterilizer, Yavne Tel Aviv, IL): 6 new FDA device listings, incl. implant, endosseous, root-form
• Spinecraft LLC (manufacturer, Westmont, IL): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Sterigenics U.S., LLC (contract sterilizer, Schaumburg, IL): 7 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• Sterigenics US LLC (contract sterilizer, Gurnee, IL): 19 new FDA device listings, incl. lipoaspirate washing system for aesthetic body contouring
• SUNSET HEALTHCARE SOLUTIONS, Inc. (repackager or relabeler, Chicago, IL): 3 new FDA device listings, incl. device, positive pressure breathing, intermittent
• TEMPUS AI, Inc. (manufacturer, Chicago, IL): 2 new FDA device listings, incl. pulmonary hypertension machine learning-based notification software
• Usr Electronic Systems (1987) Ltd (contract manufacturer, Karmiel Northern, IL): 3 new FDA device listings, incl. stimulator, muscle, powered, for muscle conditioning
• Venus Concept Ltd. (foreign exporter, Yokneam Illit Northern, IL): 3 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Veridian Healthcare LLC (repackager or relabeler, Gurnee, IL): 4 new FDA device listings, incl. clinical electronic thermometer
• Vomark Technologies Inc (repackager or relabeler, Wheeling, IL): 3 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Wondfo USA Co., Ltd. (other, Bolingbrook, IL): 11 new FDA device listings, incl. enzyme immunoassay, phencyclidine

Indiana

• Accuster Technologies Pvt. Ltd. (manufacturer, New Delhi, IN): 7 new FDA device listings, incl. slides, microscope
• Apothecaries Sundries Mfg Pvt Ltd (manufacturer, GURUGRAM Haryana, IN): 26 new FDA device listings, incl. shoe, cast
• Arcamed, LLC (contract manufacturer, Indianapolis, IN): 5 new FDA device listings, incl. screw, fixation, bone
• Arck Technologies Innovations Pvt Ltd (manufacturer, Vasai Maharashtra, IN): 4 new FDA device listings, incl. labware, assisted reproduction, exempt
• Baxter Innovations & Business Solutions Pvt. Ltd. (specification developer, Bangalore Karnataka, IN): 4 new FDA device listings, incl. system, image processing, radiological
• Biomet, Inc. (manufacturer, Warsaw, IN): 18 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Boston Scientific Corporation (manufacturer, Spencer, IN): 6 new FDA device listings, incl. kit, nephroscope
• Chlorophyllic Concepts (Opc) Private Limited (contract manufacturer, Thane Maharashtra, IN): 12 new FDA device listings, incl. shoulder prosthesis, reverse configuration
• Cook Medical LLC (contract manufacturer, Bloomington, IN): 4 new FDA device listings, incl. tube, tracheal (w/wo connector)
• Depuy Orthopaedics, Inc. (manufacturer, Warsaw, IN): 12 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented
• Dot America, Inc. (contract manufacturer, Columbia City, IN): 5 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer
• G & H Wire Company (repackager or relabeler, Franklin, IN): 2 new FDA device listings, incl. bracket, ceramic, orthodontic
• Hill-Rom, Inc. (manufacturer, Batesville, IN): 3 new FDA device listings, incl. monitor, breathing frequency
• Intersurgical Inc. (repackager or relabeler, Indianapolis, IN): 2 new FDA device listings, incl. clip, nose
• Kamal Encon Industries Limited (manufacturer, Faridabad Haryana, IN): 7 new FDA device listings, incl. dentures, full
• Kimball Solutions Jasper, Inc. (contract manufacturer, Jasper, IN): 9 new FDA device listings, incl. interventional fluoroscopic x-ray system
• Labotech Microscopes India Private Limited (manufacturer, AMBALA CANTT Haryana, IN): 2 new FDA device listings, incl. colposcope (and colpomicroscope), exempt
• Laparomed Private Limited (manufacturer, Mumbai Maharashtra, IN): 51 new FDA device listings, incl. probe, periodontic
• LifeSignals India Private Limited (contract manufacturer, Bangalore Karnataka, IN): 4 new FDA device listings, incl. outpatient cardiac telemetry
• Lifewear Technologies India Private Limited (manufacturer, Solan Himachal Pradesh, IN): 8 new FDA device listings, incl. splint, hand, and components
• Lords Mark Industries Ltd. (manufacturer, Daman and Diu Dadra and Nagar Haveli, IN): 50 new FDA device listings, incl. electrode, ion selective (non-specified)
• Medart Technology Private Limited (contract manufacturer, Valsad Gujarat, IN): 3 new FDA device listings, incl. bit, drill
• Medartis Inc. (specification developer, Warsaw, IN): 2 new FDA device listings, incl. prosthesis, elbow, hemi-, radial, polymer
• Micropulse Inc (contract manufacturer, Columbia City, IN): 45 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar
• 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
• Orthopediatrics, Corp (specification developer, Warsaw, IN): 5 new FDA device listings, incl. file
• Philips India Limited - Image Guided Therapy Systems Business Unit (contract manufacturer, Bengaluru Karnataka, IN): 6 new FDA device listings, incl. system, image processing, radiological
• 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
• 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
• Poly Medicure Ltd. (manufacturer, Faridabad Haryana, IN): 3 new FDA device listings, incl. catheter, intravascular, therapeutic, short-term less than 30 days
• Power Dental Studio Milling Pvt Ltd (manufacturer, Noida Uttar Pradesh, IN): 2 new FDA device listings, incl. alloy, metal, base
• Siemens Healthcare Pvt. Ltd. (contract manufacturer, Bangalore, IN): 3 new FDA device listings, incl. system, nuclear magnetic resonance imaging
• Steel City Health Private Limited (repackager or relabeler, Gurugram Haryana, IN): 2 new FDA device listings, incl. material, impression tray, resin
• Sterigenics Radiation Technologies IN, Inc (contract sterilizer, Columbia City, IN): 3 new FDA device listings, incl. sacroiliac joint fixation
• Viant AS&O Holdings, LLC (contract manufacturer, Indianapolis, IN): 4 new FDA device listings, incl. sterilization wrap containers, trays, cassettes & other accessories
• Wipro GE Healthcare Private Ltd. (manufacturer, Bangalore Karnataka, IN): 19 new FDA device listings, incl. automated radiological image processing software
• Wipro Ge Medical Device Manufacturing Private Limited (manufacturer, Bangalore Karnataka, IN): 19 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic

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