Data / Medical devices / Template
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
| Country | Makers |
|---|---|
| United States | 222 |
| Germany | 33 |
| France | 28 |
| Switzerland | 26 |
| China | 19 |
| United Kingdom | 6 |
| Italy | 6 |
| India | 5 |
| Ireland | 5 |
| South Korea | 5 |
| Malaysia | 5 |
| Taiwan | 4 |
| Canada | 2 |
| Belgium | 2 |
| Costa Rica | 2 |
| Mexico | 2 |
| Brazil | 2 |
| Finland | 2 |
| Japan | 2 |
| Poland | 1 |
| South Africa | 1 |
| New Zealand | 1 |
| Netherlands | 1 |
| Singapore | 1 |
| Pakistan | 1 |
| Argentina | 1 |
| Turkey | 1 |
| Colombia | 1 |
| Israel | 1 |
| Australia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3Spine, Inc. | Chattanooga, TN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 4web Inc. | Frisco, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agfa Healthcare Inc. | WATERLOO Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agfa Healthcare N.V. | MORTSEL Antwerpen, Belgium | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allergan | La Aurora De Heredia, Costa Rica | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amplitude | Valence Drome, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Resource Technologies, Inc., PPC Industries, A Spectrum Plastics Group Co. | Pittsfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptis Medical, LLC. | Glenview, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH - Quakertown | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armbruster GMBH | Steinach Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aristotech Industries GmbH | Berlin, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B-One Medical (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B-One Ortho, Corp. | Cedar Knolls, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baechler Feintech AG | Hoelstein Basel-Landschaft, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Banister Tool, Inc. | Pflugerville, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BBC Cellpack Technology AG | Villmergen Aargau, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bester Medical System SP. Z O. O. | Nowa Deba Podkarpackie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biocomposites Ltd. | Keele Staffordshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biogennix, LLC | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet France | Valence Drome, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Biomet Uk Ltd. | Bridgend, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blache Medical GMBH & Co. KG | Wellendingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blustone Synergy, LLC | Pueblo, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boedeker Plastics, Inc. | Shiner, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bonebridge AG | Zug, Switzerland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioDynamik | Lake Forest, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bricon Technology GmbH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&W Swiss, Inc. | Clayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C+a Tool Engineering, Inc. | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caira Surgical Corporation | New York, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canwell Medical Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caragh Precision | Galway Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cefimeca | La Talaudiere Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CELESTICA de MONTERREY S.A. de C.V. | Apodaca Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centex Machining, Inc. | Round Rock, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CF Plastiques | PUSIGNAN Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Geasure Medical Apparatus And Instruments Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Christian Diener GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Circumfix Solutions, Inc | Collierville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Polymer Technologies Ltd | Coalville Leicestershire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cole Instruments | Alpharetta, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coulot Decolletage | CHATELLERAULT Vienne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crossroads Extremity Systems LLC | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Catts Inc. | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cybermed Inc. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy (ireland) | CO. CORK Munster, Ireland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Intl., Ltd. | Leeds, United Kingdom | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Synthes (suzhou) Medical Devices Co., Ltd. | SUZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Ireland UC | Co. Cork Munster, Ireland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Double Medical Technology Inc. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eca Medical Instruments | Newbury Park, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elevation Spine | Monterey, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Surgical Supplies (pty) Ltd | Pretoria Gauteng, South Africa | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Enztec Limited | CHRISTCHURCH Canterbury, New Zealand | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Florence, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Extremity Medical, LLC | Parsippany, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower | Horsham, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fmi Medisch BV | Schiedam Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fong's Engineering & Manufacturing Private Limited | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Friedrich Daniels GMBH | SOLINGEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fusion Orthopedics Usa, LLC | Mesa, AZ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G21 S.R.I. | San Possidonio Modena, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesys Spine | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GLW, Inc. | Englewood Cliffs, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GM Dos Reis Industria E Comercio Ltda | Campinas Sao Paulo, Brazil | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gramercy Extremity Orthopedics, LLC. | Richardson, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gsource, LLC. | Emerson, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Aquila Precise Tools Limited | Guangzhou City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hermann Medizintechnik GMBH | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Holmed LLC | Attleboro, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| HPF S.R.L. | Forgaria nel Friuli Friuli Venezia Giulia, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haven Manufacturing | Ossian, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heraeus Medical GmbH | WEHRHEIM Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ilg Medizintechnik GMBH | DURCHHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Impact Printing And Design | Columbus, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implanet | Martillac Nouvelle-Aquitaine, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| In'tech Medical SAS | RANG DU FLIERS Pas-de-Calais, France | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| In2bones Usa, LLC | Cordova, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indius Medical Technologies Pvt. Ltd. | Pune Maharashtra, India | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innotool&greminger AG | Erlen Thurgau, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Microfrance SAS | SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| In2Bones SAS | Saint-Priest Rhone, France | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices SA | St Blaise Neuchatel, Switzerland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intrinsic Therapeutics, Inc. | Woburn, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JMG Machine, Inc. | La Mirada, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Balsthal) | Balsthal Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Bettlach) | Bettlach Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Grenchen) | Grenchen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Hagendorf) | Hagendorf Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Le Locle) | Le Locle Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Raron) | Raron Valais, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Tuttlingen Manufacturing GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K2M, Inc. | Leesburg, VA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kapp Surgical, Inc. | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kapstone Manufacturing | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Manufacturing, LLC | Jacksonville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Se & Co. KG | Fridingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ksi Co., Ltd. | Gotemba Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kalitec Direct LLC DBA Kalitec Medical | Sarasota, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&K Biomed Co.,ltd. | Yongin-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios SL SA | Malvinas Argentinas Buenos Aires, Argentina | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leitner AG | Busswil Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lento Medical Innovation, Inc. | Houston, TX, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Limacorporate S.p.A. | Villanova di San Daniele Udine, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical LLC | Vandalia, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LinkBio Corp. | Dover, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Longeviti Neuro Solutions | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mack Molding Company | Arlington, VT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maire-Didier | Chaumont Haute-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marle Finishing SAS | La Talaudiere Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mectalent Ltd. | Oulu Kainuu, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medartis AG | BASEL Basel-Stadt, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Solutions GMBH | Emmingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Conteneur SAS | SAINT-SOUPPLETS Seine-et-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Group | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicrea International | RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDITEC SOURCE GmbH & Co. KG | Tuttlingen-Nendingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medmetalex Co., Ltd. | Osaka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech LLC | Millington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merete GMBH | Berlin, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Orthopedics Inc. | Arlington, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtechnic | CROLLES Isere, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microware Precision Co., Ltd. | Taichung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mikron Makina Sanayi Ve Ticaret Ltd. Sti. | Ivedik Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millennium Surgical Corp | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miraclus Orthotech Private Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moser-Baer AG | Sumiswald Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moximed, Inc. | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MPS Micro Precision Systems AG | Biel-Bienne Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mack Proto | Gardner, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masterbilt Incorporated | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise Colombia S.A.S | Medellin Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Medical Costa Rica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mendell | Lakeville, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merge Healthcare Incorporated | Hartland, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neoortho Produtos Ortopedicos S/A | Curitiba Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newclip Technics SAS | HAUTE GOULAINE Loire-Atlantique, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus CMF | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus Spine, L.L.C. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus Spine, LLC. | Lehi, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NuVasive Specialized Orthopedics, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oberg Medical Products Company | Sarver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oeb S.R.L. | Camposanto Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omega Plastics, Inc. | Clinton Township, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onkos Surgical, Inc. | Parsippany, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedics-Chelsea | Chelsea, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Development Corp. | Draper, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthofix Us LLC | Lewisville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osartis GMBH | Muenster Hesse, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossio Ltd. | Caesarea Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomed | Addison, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteoremedies, LLC | Memphis, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteotec Limited | Newbury West Berkshire, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oury-Guye & Fils | NOGENT Haute-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Overture Orthopaedics | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OrthAlign, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions Sdn Bhd | Prai, Penang Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopedic Designs North America, Inc. | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Instruments Inc. | Honolulu, HI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paonan Biotech Co., Ltd | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul Buetiger AG | Biberist Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phen'x Technologies | Chassieu Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poriferous, LLC | Newnan, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precera Medical Herouville SAS | HEROUVILLE ST CLAIR CEDEX Normandie, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Adm | Winnipeg Manitoba, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Castleton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Precision Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies- North Manchester Manufacturing Facility | N Manchester, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Spine, Inc. | Pearl, MS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ProMed Concepts, LLC | Brighton, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayco Steel Process, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Red Star Contract Manufacturing Inc. | Larwill, IN, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S. Jackson, Inc. | Alexandria, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.M.A.I.O | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samaplast AG | Sankt Margrethen Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scotty Medical, LLC | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Serf | DECINES CHARPIEU Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sferic | MENARS Centre-Val de Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shalby Advanced Technologies, Inc. | El Dorado Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheffield Precision Medical Ltd | Sheffield, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SIGN Fracture Care International | Richland, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signature Orthopaedics Pty Limited | Sydney New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signus Medizintechnik GMBH | ALZENAU Bavaria, Germany | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Single Source Medical LLC | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sky Surgical | Parkville, MO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smithstown Light Engineering | Shannon Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solco Biomedical Company India Private Limited | KADI Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sphinx Tools Ltd | Derendingen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spine Wave, Inc. | Shelton, CT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spineart SA | Plan-les-Ouates, Switzerland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinevision SAS | Antony Hauts-de-Seine, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SQ Products AG | Inwil Luzern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sti Lualdi S.R.L. | Casiacco Pordenone, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stork Instrumente GMBH | Emmingen-Liptingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Ireland Osteonics | County Cork, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Spine | Allendale, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit MFG. And Machining, Inc. | Bremen, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou And Science & Technology Development Corp. | Zhangjiagang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou Jiangsu, China | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Lansing, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanbor Medical Xiamen, Inc. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Malaysia Sdn Bhd (758243-M) | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T & L Sharpening, Inc. | Indiana Beach, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tech-Etch, Inc. | Plymouth, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet | Woburn, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet, Inc. | Kenosha, WI, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecres SPA | VERONA Veneto, Italy | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theken Companies, LLC | Akron, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOMZ Corporation | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Total Joint Orthopedics, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trigon America LLC | Aurora, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trimed, Inc. | Santa Clarita, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Titan Spine, a Division of Medtronic | Milwaukee, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tornier S.A.S. | Montbonnot Saint-Martin Isere, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trilliant Surgical LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Orthopedic Corp. | Kaohsiung, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Orthopedic Corporation | Hsinchu Hsinchu(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unity Tool, Inc. | Osseo, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| VCN Technologies | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visionare LLC | Fort Myers, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VanDuzen, Inc. dba MedCAD | Dallas, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Chaumont S.A.S. | CHAUMONT Haute-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W+S Solutions GMBH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Warema Kunststofftechnik Und Maschinenbau GMBH | Marktheidenfeld Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| West-Conn Tool And Die Inc | Shelton, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westlake Plastics Europe | TOURCOING Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenix Medical | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinhua Healthcare Industry Co.,limited | Zibo Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zigg Design LLC | Nibley, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer GMBH | WINTERTHUR Zurich, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Manufacturing B.V. | Mercedita, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 0 | 0 | 7 | 0 | api.fda.gov | |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZimVie US Corp LLC | Palm Beach Gardens, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Trabecular Metal Technology, Inc. | Parsippany, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| b-ONE Ortho Corp. | Fairfield, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| implantcast GmbH | Buxtehude Lower Saxony, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| restor3d, inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.