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Data / Medical devices / Hammer, Surgical

Hammer, Surgical (FZY): 232 FDA-registered makers in 15 countries

232 establishments in 15 countries are registered with the FDA to make Hammer, Surgical (product code FZY, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 12, 1980, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FZY
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States79
Pakistan62
Germany40
China15
Switzerland8
India7
France5
South Korea5
Ireland3
Italy2
Australia2
Canada1
Taiwan1
United Kingdom1
Mexico1

Makers of Hammer, Surgical

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
A.handte Medizintechnik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Aap Implantate AGBerlin, GermanyManufacturer0000api.fda.gov
Accuratus AGBern, SwitzerlandManufacturer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
ALVI ExpoSialkot Punjab, PakistanManufacturer0000api.fda.gov
AmplitudeValence Drome, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Armatech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Armbruster GMBHSteinach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avilign MedicalSialkot Punjab, PakistanContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Aristotech Industries GmbHBerlin, GermanyContract manufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Bauer Und Haselbarth-Chirurg GMBHELLERAU Schleswig-Holstein, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Beijing Fule Science & Technology Development Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
BIEDERMANN MOTECH GMBH & Co. KGVS-SCHWENNINGEN Baden-Wurttemberg, GermanyManufacturer, Specification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Blache Medical GMBH & Co. KGWellendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Bodycad Laboratories, Inc.Quebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Biopsy Fine Cut InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Central Surgical Co. Pvt. Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
CG MedTech Co., Ltd.Uijeongbu-si Gyeonggi, South KoreaComplaint file establishment, Manufacturer0000api.fda.gov
Chin Kou Medical Instrument Co.,ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Concise EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
CnS MEDICAL CO., LTD.Pocheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
Darleys Surgical Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Den Tag S.R.L.MANIAGO, PN. Pordenone, ItalyManufacturer0000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandSpecification developer0000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomSpecification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Diligent Medical ServicesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Doctor DevicesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Doppkon GMBH & Co. KGSpaichingen Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
DR. Frigz International (pvt) Ltd.SIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Depuy Ireland UCCo. Cork Munster, IrelandSpecification developer0000api.fda.gov
Elmed Instruments (pvt). Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Eltek Instruments (pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesSpecification developer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Fenghua Tealmed Emergency Products Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G.A. Surgical (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hazel EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
HONER Medizin-Technik GmbH & Co. KGSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Hoogland Spine Products GmbHUnterfoehring Munich Bavaria, GermanyExporter to the US, Specification developer0000api.fda.gov
In'tech Medical SASRANG DU FLIERS Pas-de-Calais, FranceContract manufacturer, Exporter to the US0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Infirmary Medical SuppliesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jay-MedSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
JMG Machine, Inc.La Mirada, CA, United StatesContract manufacturer0000api.fda.gov
Joimax GMBHKARLSRUHE Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
L&K Biomed Co.,ltd.Yongin-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Little Doctor Electronic(nantong) Co.,ltdNantong Jiangsu, ChinaSpecification developer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
M.J. Instruments Company (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Madina Surgical WorksSialkot Punjab, PakistanManufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Maryam TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
MctbioYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
MEDESY srlMANIAGO Pordenone, ItalyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Merete GMBHBerlin, GermanySpecification developer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Miraclus Orthotech Private LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Mts Brothers Surgical InstrumentsPunjab, PakistanManufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Nawaz And SonsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Ningbo Yongjin Medical Instruments Manufacture Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesManufacturer0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
OsteomedAddison, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Ptumedical GMBHSpaichingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Sabokay IndustriesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer0000api.fda.gov
Shanghai Kangqiao Dental Instruments FactoryShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Si-Bone, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Si-Bone, Inc.Santa Clara, CA, United StatesManufacturer0000api.fda.gov
Signature Orthopaedics Pty LimitedSydney New South Wales, AustraliaManufacturer, Specification developer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Sitec (pvt.) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Skill To Tech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Solatch SonsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Spinevision SASAntony Hauts-de-Seine, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Sterramed IncWeehawken, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Storz Am Mark GMBHEMMINGEN-LIPTINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgikareSIALKOT Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Surgin Surgical Instrumentation, Inc.Scottsdale, AZ, United StatesSpecification developer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurjexSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Signature Orthopaedics Europe LtdAthlone Westmeath, IrelandManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stengelin Medical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
T.A. Walthem & CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Theken Companies, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Turnxon Precision Co., LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tornier S.A.S.Montbonnot Saint-Martin Isere, FranceComplaint file establishment, Specification developer0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Washington Surgical InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Wenzhou Caretek Medical Device Co., LtdWenzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Wenzhou Dongfang Medical Instruments Co., LtdWENZHOU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wenzhou Kangshun Medical Devices Co.,ltd.Wenzhou City Zhejiang, ChinaManufacturer0000api.fda.gov
Wenzhou Longwan Medical Device FactoryWenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Weldon InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Xinhua Healthcare Industry Co.,limitedZibo Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandManufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
e.l. zepf GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
implantcast GmbHBuxtehude Lower Saxony, GermanyComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 12, 1980. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.