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Data / Medical devices / Tap, Bone

Tap, Bone (HWX): 268 FDA-registered makers in 24 countries

268 establishments in 24 countries are registered with the FDA to make Tap, Bone (product code HWX, Class 1, 21 CFR 888.4540). 0 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on September 2, 1987, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
HWX
Device class
1
Regulation
888.4540
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States152
Germany33
Switzerland17
France13
China10
India10
South Korea7
Pakistan5
Malaysia3
Mexico2
Finland2
Taiwan2
Poland1
Costa Rica1
Ireland1
United Kingdom1
Netherlands1
Colombia1
Brazil1
Japan1
Turkey1
South Africa1
Israel1
Austria1

Makers of Tap, Bone

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
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Aap Implantate AGBerlin, GermanyManufacturer0000api.fda.gov
Accufix Surgical, Inc.Laramie, WY, United StatesSpecification developer0000api.fda.gov
Aegis Meditec, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
Alva Prototypes IncPottstown, PA, United StatesContract manufacturer, Remanufacturer0000api.fda.gov
AMETEK Poland sp. z o.o.Siechnice Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - ElmhurstElmhurst, IL, 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 - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Aristotech Industries GmbHBerlin, GermanyContract manufacturer0000api.fda.gov
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Baeramed Instrumente GMBHSCHWENNINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract 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 FranceValence Drome, FranceManufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
BK Meditech Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Canwell Medical Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov
Cayenne Medical, Inc.Scottsdale, AZ, United StatesManufacturer0000api.fda.gov
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
CG MedTech Co., Ltd.Uijeongbu-si Gyeonggi, South KoreaComplaint file establishment, Manufacturer0000api.fda.gov
Changzhou Centrau Medical Instrument Co.,ltd.CHANGZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Geasure Medical Apparatus And Instruments Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Corentec Co., Ltd.Cheonan Si, Chungnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesManufacturer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesSpecification developer0000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandManufacturer, Specification developer0000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Diamond OrthopedicGastonia, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Dunamis Medical LLCGreenville, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer0000api.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
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Euclide CareAixe Sur Vienne Haute-Vienne, FranceContract manufacturer0000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Flospine LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus FlowerHorsham, PA, United StatesSpecification developer0000api.fda.gov
Fmi Medisch BVSchiedam Zuid-Holland, NetherlandsContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer0000api.fda.gov
GPC Medical LimitedGhaziabad Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Gramercy Extremity Orthopedics, LLC.Richardson, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Guangzhou Aquila Precise Tools LimitedGuangzhou City Guangdong, ChinaContract manufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer0000api.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
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Iconn Orthopedics, LLCBirmingham, AL, United StatesComplaint file establishment, Manufacturer, 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
Indius Medical Technologies Pvt. Ltd.Pune Maharashtra, IndiaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Industrias Medicas Sampedro S.A.SLa Estrella Antioquia, ColombiaManufacturer0000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer, Specification developer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
ITM Industria de Tecnologias Medicas LTDACANOAS Rio Grande do Sul, BrazilManufacturer0000api.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 manufacturer0000api.fda.gov
Jeil Medical CorporationSeoul, South KoreaManufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Balsthal)Balsthal Solothurn, SwitzerlandContract 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 Switzerland Manufacturing GmbH (Le Locle)Le Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)Mezzovico Ticino, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Ksi Co., Ltd.Gotemba Shizuoka, JapanContract manufacturer0000api.fda.gov
Kyin Manufacturing, LLCLouisville, KY, United StatesSpecification developer0000api.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
LDR MedicalSainte-Savine Aube, FranceSpecification developer0000api.fda.gov
Lenox-Maclaren Surgical Corp.Louisville, CO, United StatesManufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maire-DidierChaumont Haute-Marne, FranceContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Marida, Marianne Daniels Chir. Instr.SOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Mat GMBH & Co. KGEmmingen-Liptingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Mectalent Ltd.Oulu Kainuu, FinlandContract manufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medical Component SpecialistsBellingham, MA, United StatesContract manufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Medicrea InternationalRILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FranceManufacturer0000api.fda.gov
MEDITEC SOURCE GmbH & Co. KGTuttlingen-Nendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medizintechnik Sattler GMBHKoenigsee Thuringia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.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
Merete GMBHBerlin, GermanySpecification developer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesReprocessor0000api.fda.gov
Miing Wei Co., Ltd.Tsao-Twon Nantou, TaiwanContract manufacturer0000api.fda.gov
Mikron Makina Sanayi Ve Ticaret Ltd. Sti.Ivedik Ankara, TurkeyManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Miraclus Orthotech Private LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Moser-Baer AGSumiswald Bern, SwitzerlandContract manufacturer0000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0010api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.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
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer, Specification developer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Neo Medical S.A.Villette (Lavaux) Vaud, SwitzerlandSpecification developer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Ortho CapeMontauban Tarn-et-Garonne, FranceContract manufacturer, Manufacturer0000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho-DesignPretoria Gauteng, South AfricaSpecification developer0000api.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
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ossio Ltd.Caesarea Central, IsraelManufacturer0000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer0000api.fda.gov
Osteonic Co., Ltd.Seoul, South KoreaManufacturer0000api.fda.gov
Otto Leibinger GMBHMUEHLHEIM Baden-Wurttemberg, GermanyContract 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
Orthopedic Designs North America, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
Pace SurgicalMalvern, PA, United StatesSpecification developer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Paonan Biotech Co., LtdTaipei, TaiwanManufacturer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Ptumedical GMBHSpaichingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Precision Edge Surgical Products Co LLCBoyne City, MI, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products, LLCAngola, IN, United StatesContract manufacturer0000api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesManufacturer0000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
ProMed Concepts, LLCBrighton, TN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesSpecification developer0000api.fda.gov
Ruetschi Technology AGMuntelier Fribourg, SwitzerlandContract manufacturer0000api.fda.gov
S. S. White Technologies India Pvt. Ltd.Surendranagar Gujarat, IndiaContract manufacturer, Exporter to the US0000api.fda.gov
S.M.A.I.OSAINT-PRIEST Auvergne-Rhone-Alpes, FranceManufacturer, Specification developer0000api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla MedicalSt Petersburg, FL, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Science & Bio Materials, S.B.M. SASLOURDES Hautes-Pyrenees, FranceComplaint file establishment, Manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Shanghai Reach Medical Instrument Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Silony Medical GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanyManufacturer, Specification developer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0010api.fda.gov
Solco Biomedical Company India Private LimitedKADI Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Sphinx Tools LtdDerendingen Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Spine Wave, Inc.Shelton, CT, United StatesManufacturer, Specification developer0000api.fda.gov
Spineart SAPlan-les-Ouates, SwitzerlandComplaint file establishment, Specification developer0000api.fda.gov
Spinevision SASAntony Hauts-de-Seine, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Suretek MedicalGreenville, SC, United StatesReprocessor0000api.fda.gov
Surgebright GMBHLichtenberg Oberosterreich, AustriaExporter to the US, Specification developer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandSpecification developer0000api.fda.gov
Schilling CNC-Technik GmbHMUHLHEIM-STETTEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Teknimed SASL Union Haute-Garonne, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Troy Innovative Instruments Co LLCMiddlefield, OH, United StatesContract 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
The E F PRECISION GROUPWillow Grove, PA, United StatesContract manufacturer0000api.fda.gov
Tornier S.A.S.Montbonnot Saint-Martin Isere, FranceManufacturer0000api.fda.gov
TriPoint SurgicalColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Ulrich Medical Usa, Inc.Plano, TX, United StatesSpecification developer0000api.fda.gov
Unity Tool, Inc.Osseo, MN, United StatesContract manufacturer0000api.fda.gov
Unified Spine, LLCWesterville, OH, United StatesManufacturer, Specification developer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
West-Conn Tool And Die IncShelton, CT, United StatesContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandManufacturer0010api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
medi-plus Instrumente GmbHTUTTLINGEN-NENDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated September 2, 1987. 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.