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Template (HWT): 389 FDA-registered makers in 30 countries

389 establishments in 30 countries are registered with the FDA to make Template (product code HWT, Class 1, 21 CFR 888.4800). 0 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on February 18, 1998, and lists 23 recall events (0 Class I). FDA data exported November 3, 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
HWT
Device class
1
Regulation
888.4800
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States222
Germany33
France28
Switzerland26
China19
United Kingdom6
Italy6
India5
Ireland5
South Korea5
Malaysia5
Taiwan4
Canada2
Belgium2
Costa Rica2
Mexico2
Brazil2
Finland2
Japan2
Poland1
South Africa1
New Zealand1
Netherlands1
Singapore1
Pakistan1
Argentina1
Turkey1
Colombia1
Israel1
Australia1

Makers of Template

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
3Spine, Inc.Chattanooga, TN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Agfa Healthcare Inc.WATERLOO Ontario, CanadaSpecification developer0000api.fda.gov
Agfa Healthcare N.V.MORTSEL Antwerpen, BelgiumComplaint file establishment, Manufacturer0000api.fda.gov
AllerganLa Aurora De Heredia, Costa RicaSpecification developer0000api.fda.gov
Allergan Sales, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
AmplitudeValence Drome, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Apex Resource Technologies, Inc., PPC Industries, A Spectrum Plastics Group Co.Pittsfield, MA, United StatesContract manufacturer0000api.fda.gov
Aptis Medical, LLC.Glenview, KY, United StatesManufacturer0000api.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 - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Armbruster GMBHSteinach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer0000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Aristotech Industries GmbHBerlin, GermanyContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B-One Medical (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
B-One Ortho, Corp.Cedar Knolls, NJ, United StatesManufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
BBC Cellpack Technology AGVillmergen Aargau, SwitzerlandContract manufacturer0000api.fda.gov
Beijing Fule Science & Technology Development Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Bester Medical System SP. Z O. O.Nowa Deba Podkarpackie, PolandContract manufacturer0000api.fda.gov
Biocomposites Ltd.Keele Staffordshire, United KingdomSpecification developer0000api.fda.gov
Biogennix, LLCIrvine, CA, United StatesSpecification developer0000api.fda.gov
Biomet FranceValence Drome, FranceManufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Specification developer0010api.fda.gov
Biomet Uk Ltd.Bridgend, United KingdomSpecification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0030api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Blache Medical GMBH & Co. KGWellendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Blustone Synergy, LLCPueblo, CO, United StatesSpecification developer0000api.fda.gov
Boedeker Plastics, Inc.Shiner, TX, United StatesContract manufacturer0000api.fda.gov
Bonebridge AGZug, SwitzerlandComplaint file establishment, Specification developer0000api.fda.gov
BioDynamikLake Forest, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Bricon Technology GmbHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Caira Surgical CorporationNew York, NY, United StatesSpecification developer0000api.fda.gov
Canwell Medical Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov
Caragh PrecisionGalway Galway(County), IrelandContract manufacturer0000api.fda.gov
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer0000api.fda.gov
CF PlastiquesPUSIGNAN Rhone, FranceContract manufacturer0000api.fda.gov
CG MedTech Co., Ltd.Uijeongbu-si Gyeonggi, South KoreaComplaint file establishment, Manufacturer0000api.fda.gov
Changzhou Geasure Medical Apparatus And Instruments Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Circumfix Solutions, IncCollierville, TN, United StatesSpecification developer0000api.fda.gov
Clinical Polymer Technologies LtdCoalville Leicestershire, United KingdomContract manufacturer0000api.fda.gov
Cole InstrumentsAlpharetta, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Cook Biotech, Inc.West Lafayette, IN, United StatesManufacturer0000api.fda.gov
Corentec Co., Ltd.Cheonan Si, Chungnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Coulot DecolletageCHATELLERAULT Vienne, FranceContract manufacturer0000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesManufacturer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Catts Inc.Fort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Cybermed Inc.Daejeon, South KoreaManufacturer0000api.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 developer0030api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.SUZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Depuy Ireland UCCo. Cork Munster, IrelandManufacturer, Specification developer0000api.fda.gov
Double Medical Technology Inc.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Elevation SpineMonterey, CA, United StatesSpecification developer0000api.fda.gov
Elite Surgical Supplies (pty) LtdPretoria Gauteng, South AfricaComplaint file establishment, Contract manufacturer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer0010api.fda.gov
Enztec LimitedCHRISTCHURCH Canterbury, New ZealandContract manufacturer, Manufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer, Repackager or relabeler0000api.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
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
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus FlowerHorsham, PA, United StatesSpecification developer0000api.fda.gov
Fmi Medisch BVSchiedam Zuid-Holland, NetherlandsContract manufacturer0000api.fda.gov
Fong's Engineering & Manufacturing Private LimitedSingapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
Friedrich Daniels GMBHSOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G21 S.R.I.San Possidonio Modena, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
GLW, Inc.Englewood Cliffs, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
GM Dos Reis Industria E Comercio LtdaCampinas Sao Paulo, BrazilManufacturer, Repackager or relabeler0000api.fda.gov
Gramercy Extremity Orthopedics, LLC.Richardson, TX, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.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
Guangzhou Clean Medical Products Manufacturing CorpGuangzhou Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer0020api.fda.gov
HPF S.R.L.Forgaria nel Friuli Friuli Venezia Giulia, ItalyManufacturer0000api.fda.gov
Haven ManufacturingOssian, IN, United StatesContract manufacturer0000api.fda.gov
Heraeus Medical GmbHWEHRHEIM Hesse, GermanyManufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ilg Medizintechnik GMBHDURCHHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Impact Printing And DesignColumbus, OH, United StatesContract manufacturer0000api.fda.gov
ImplanetMartillac Nouvelle-Aquitaine, FranceManufacturer0000api.fda.gov
In'tech Medical SASRANG DU FLIERS Pas-de-Calais, FranceContract manufacturer, Exporter to the US0000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesManufacturer, Repackager or relabeler0000api.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
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer, Specification developer0000api.fda.gov
Innotool&greminger AGErlen Thurgau, SwitzerlandContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
In2Bones SASSaint-Priest Rhone, FranceExporter to the US, Specification developer0000api.fda.gov
Incipio Devices SASt Blaise Neuchatel, SwitzerlandComplaint file establishment, 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
Intrinsic Therapeutics, Inc.Woburn, MA, United StatesManufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jeil Medical CorporationSeoul, South KoreaManufacturer0000api.fda.gov
JMG Machine, Inc.La Mirada, CA, United StatesContract manufacturer0000api.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 (Grenchen)Grenchen 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 Switzerland Manufacturing GmbH (Raron)Raron Valais, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer0000api.fda.gov
Kapp Surgical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
Kapstone ManufacturingCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
KLS Martin Se & Co. KGFridingen Baden-Wurttemberg, GermanyContract manufacturer0000api.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
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
Laboratorios SL SAMalvinas Argentinas Buenos Aires, ArgentinaContract manufacturer0000api.fda.gov
LDR MedicalSainte-Savine Aube, FranceSpecification developer0000api.fda.gov
Leitner AGBusswil Bern, SwitzerlandContract manufacturer0000api.fda.gov
Lento Medical Innovation, Inc.Houston, TX, United StatesManufacturer for export0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Limacorporate S.p.A.Villanova di San Daniele Udine, ItalyManufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
LinkBio Corp.Dover, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Longeviti Neuro SolutionsBaltimore, MD, United StatesManufacturer0000api.fda.gov
Mack Molding CompanyArlington, VT, United StatesContract manufacturer0000api.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 StatesManufacturer0000api.fda.gov
Marle Finishing SASLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Materialise N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer0000api.fda.gov
Mectalent Ltd.Oulu Kainuu, FinlandContract manufacturer0000api.fda.gov
Medartis AGBASEL Basel-Stadt, SwitzerlandManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medical Conteneur SASSAINT-SOUPPLETS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
Medical GroupSAINT-PRIEST Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer0000api.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
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medmetalex Co., Ltd.Osaka, JapanContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler0000api.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 StatesContract manufacturer0000api.fda.gov
MicrotechnicCROLLES Isere, FranceContract manufacturer0000api.fda.gov
Microware Precision Co., Ltd.Taichung, TaiwanContract manufacturer0000api.fda.gov
Mikron Makina Sanayi Ve Ticaret Ltd. Sti.Ivedik Ankara, TurkeyManufacturer0000api.fda.gov
Millennium Surgical CorpSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.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
Moximed, Inc.Fremont, CA, United StatesManufacturer0000api.fda.gov
MPS Micro Precision Systems AGBiel-Bienne Bern, SwitzerlandContract manufacturer0000api.fda.gov
Mack ProtoGardner, MA, United StatesContract manufacturer0000api.fda.gov
Masterbilt IncorporatedSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Materialise Colombia S.A.SMedellin Antioquia, ColombiaManufacturer0000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer0010api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Medtronic Medical Costa Rica S.R.L.Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Merge Healthcare IncorporatedHartland, WI, United StatesManufacturer0000api.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
Neoortho Produtos Ortopedicos S/ACuritiba Parana, BrazilManufacturer0000api.fda.gov
Newclip Technics SASHAUTE GOULAINE Loire-Atlantique, FranceManufacturer0000api.fda.gov
Nexus CMFSalt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesSpecification developer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
NuVasive Specialized Orthopedics, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Oeb S.R.L.Camposanto Modena, ItalyContract manufacturer0000api.fda.gov
Omega Plastics, Inc.Clinton Township, MI, United StatesContract manufacturer0000api.fda.gov
Onkos Surgical, Inc.Parsippany, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Oregon, Inc.Oregon City, OR, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.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
Osartis GMBHMuenster Hesse, GermanySpecification developer0000api.fda.gov
Ossio Ltd.Caesarea Central, IsraelManufacturer0000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Osteoremedies, LLCMemphis, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Osteotec LimitedNewbury West Berkshire, United KingdomExporter to the US, Specification developer0000api.fda.gov
Oury-Guye & FilsNOGENT Haute-Marne, FranceContract manufacturer0000api.fda.gov
Overture OrthopaedicsIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
OrthAlign, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho Solutions Sdn BhdPrai, Penang Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Orthopedic Designs North America, Inc.Tampa, FL, United StatesManufacturer0000api.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
Paul Buetiger AGBiberist Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Phen'x TechnologiesChassieu Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Poriferous, LLCNewnan, GA, United StatesManufacturer0000api.fda.gov
Precera Medical Herouville SASHEROUVILLE ST CLAIR CEDEX Normandie, FranceContract manufacturer0000api.fda.gov
Precision AdmWinnipeg Manitoba, CanadaContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract 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 Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesContract manufacturer0000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer0000api.fda.gov
ProMed Concepts, LLCBrighton, TN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Rayco Steel Process, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Red Star Contract Manufacturing Inc.Larwill, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
S. Jackson, Inc.Alexandria, VA, United StatesManufacturer0000api.fda.gov
S.M.A.I.OSAINT-PRIEST Auvergne-Rhone-Alpes, FranceManufacturer, Specification developer0000api.fda.gov
Samaplast AGSankt Margrethen Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Scotty Medical, LLCNew York, NY, United StatesManufacturer0000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
SerfDECINES CHARPIEU Rhone, FranceManufacturer0000api.fda.gov
SfericMENARS Centre-Val de Loire, FranceContract manufacturer0000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Sheffield Precision Medical LtdSheffield, United KingdomContract manufacturer0000api.fda.gov
SIGN Fracture Care InternationalRichland, WA, United StatesManufacturer0000api.fda.gov
Signature Orthopaedics Pty LimitedSydney New South Wales, AustraliaManufacturer0000api.fda.gov
Signus Medizintechnik GMBHALZENAU Bavaria, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Sky SurgicalParkville, MO, United StatesComplaint file establishment, 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.Mansfield, MA, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smithstown Light EngineeringShannon Clare, IrelandContract manufacturer0000api.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
SQ Products AGInwil Luzern, SwitzerlandContract manufacturer0000api.fda.gov
Sti Lualdi S.R.L.Casiacco Pordenone, ItalyContract manufacturer0000api.fda.gov
Stork Instrumente GMBHEmmingen-Liptingen Baden-Wurttemberg, GermanyContract 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
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Stryker Ireland OsteonicsCounty Cork, IrelandManufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Stryker SpineAllendale, NJ, United StatesManufacturer, Specification developer0000api.fda.gov
Summit MFG. And Machining, Inc.Bremen, IN, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Suzhou And Science & Technology Development Corp.Zhangjiagang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Microport Orthorecon Co., Ltd.Suzhou Jiangsu, ChinaComplaint file establishment, Contract manufacturer, Repackager or relabeler0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Lansing, MI, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Sanbor Medical Xiamen, Inc.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Suzhou Ahno Medical Devices Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.Kunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov
Symmetry Medical Malaysia Sdn Bhd (758243-M)Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Tech-Etch, Inc.Plymouth, MA, United StatesContract manufacturer0000api.fda.gov
TecometWoburn, MA, United StatesContract manufacturer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Tecres SPAVERONA Veneto, ItalyContract manufacturer, Manufacturer0000api.fda.gov
Theken Companies, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Total Joint Orthopedics, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesManufacturer0000api.fda.gov
Trigon America LLCAurora, IL, United StatesContract manufacturer0000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer0000api.fda.gov
Tornier S.A.S.Montbonnot Saint-Martin Isere, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesComplaint 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
United Orthopedic Corp.Kaohsiung, TaiwanExporter to the US, Manufacturer0000api.fda.gov
United Orthopedic CorporationHsinchu Hsinchu(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Unity Tool, Inc.Osseo, MN, United StatesContract manufacturer0000api.fda.gov
UOC USA Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
VCN TechnologiesSAINT-PRIEST Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Visionare LLCFort Myers, FL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer0000api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.fda.gov
Viant Chaumont S.A.S.CHAUMONT Haute-Marne, FranceContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
W+S Solutions GMBHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Warema Kunststofftechnik Und Maschinenbau GMBHMarktheidenfeld Bavaria, GermanyContract manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
West-Conn Tool And Die IncShelton, CT, United StatesContract manufacturer0000api.fda.gov
Westlake Plastics EuropeTOURCOING Nord, FranceContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesSpecification developer0000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Xinhua Healthcare Industry Co.,limitedZibo Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesManufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0070api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov
ZimVie US Corp LLCPalm Beach Gardens, FL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesManufacturer0000api.fda.gov
b-ONE Ortho Corp.Fairfield, NJ, United StatesSpecification developer0000api.fda.gov
implantcast GmbHBuxtehude Lower Saxony, GermanyComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
restor3d, inc.Durham, NC, United StatesManufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated February 18, 1998. 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.