Data / Medical devices / Bender
Bender (HXW): 194 FDA-registered makers in 14 countries
194 establishments in 14 countries are registered with the FDA to make Bender (product code HXW, Class 1, 21 CFR 888.4540). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on October 15, 1987, and lists 2 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
- HXW
- Device class
- 1
- Regulation
- 888.4540
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 105 |
| Germany | 30 |
| France | 12 |
| Switzerland | 9 |
| China | 8 |
| South Korea | 8 |
| India | 8 |
| Pakistan | 5 |
| Taiwan | 4 |
| Netherlands | 1 |
| Australia | 1 |
| Mexico | 1 |
| Japan | 1 |
| Turkey | 1 |
Makers of Bender
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 |
|---|---|---|---|---|---|---|---|---|
| 4web Inc. | Frisco, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Addn Solutions GMBH & Co. KG | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aegis Meditec, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Technologies | Wilsonville, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpes CN SAS | Reignier-Esery Haute-Savoie, France | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Elmhurst | Elmhurst, IL, 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 - Olive Branch | Olive Branch, MS, 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 | |
| ARCH-MedTorque | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asanus Medizintechnik GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer | 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 | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | 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 | |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BK Meditech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | 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 | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cefimeca | La Talaudiere Loire, 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 | |
| CM Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract 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 | |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curiteva, Inc. | Tanner, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 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 | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flospine LLC | Boca Raton, FL, United States | 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 | |
| Friedrich Daniels GMBH | SOLINGEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G. Hipp & Sohn GMBH | NEUHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesys Spine | Austin, TX, United States | Manufacturer | 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 | |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | 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 | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexamed Pvt Ltd | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro International (pvt) Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hive International Pvt Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Holmed LLC | Attleboro, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 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 | |
| In'tech Medical SAS | RANG DU FLIERS Pas-de-Calais, France | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indius Medical Technologies Pvt. Ltd. | Pune Maharashtra, India | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inka Surgical Instruments | Jandakot Western Australia, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumental Machine & Development, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intelivation Technologies, LLC | Plymouth Meeting, PA, United States | Complaint file establishment, Manufacturer, 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 | |
| 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 | |
| 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 | |
| Jabil Inc. (Brandywine) | W Chester, PA, 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 (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 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 GMBH | DUERBHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Klappenecker GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | 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 | |
| Kreidler Medizintechnik GmbH | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 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 | |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 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 | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maxxos-Medical GMBH | Mahlstetten Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med2b Ltd. | Kitzingen Bavaria, Germany | 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 Group | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, 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 | |
| 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 | 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 | |
| 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 | Reprocessor | 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 | |
| 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 | |
| Mount MFG | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medartis Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | 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 | |
| Nanovis Spine, LLC | Columbia City, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neo Medical S.A. | Villette (Lavaux) Vaud, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newclip Technics SAS | HAUTE GOULAINE Loire-Atlantique, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nvision Biomedical Technologies, Inc | San Antonio, TX, United States | Repackager or relabeler, Specification developer | 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 | Complaint file establishment, 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 | |
| Osteomed | Addison, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteonic Co., Ltd. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oury-Guye & Fils | NOGENT Haute-Marne, France | Contract manufacturer | 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 | |
| Pacific Instruments Inc. | Honolulu, HI, United States | Contract manufacturer, 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 | |
| Pro-Med Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | 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 | |
| Rayco Steel Process, Inc. | Warsaw, IN, United States | Contract 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 | |
| Ruetschi Technology AG | Muntelier Fribourg, Switzerland | Contract 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 | |
| S.S. White Technologies, Inc. / Dba Shukla Medical | St Petersburg, FL, United States | Contract manufacturer, 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 | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Reach Medical Instrument Co., Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SIGN Fracture Care International | Richland, WA, United States | Manufacturer | 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. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMT Schilling Metalltechnik GMBH | MUHLHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solco Biomedical Company India Private Limited | KADI Gujarat, India | Contract sterilizer, 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 | |
| Sterramed Inc | Weehawken, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stone Instruments Co. | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SUBAN Instruments Germany GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | 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 | |
| Surgicon Pvt Ltd | Sialkot Punjab, Pakistan | Manufacturer | 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 | |
| Syntec Scientific Corp. | CHANG HUA Changhua, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TDM Co.,ltd | Buk-gu Gwangju, South Korea | 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 | |
| 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 | |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL, United States | Complaint file establishment, 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 | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trilliant Surgical LLC | Houston, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 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 | |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Von Zabern Surgical | Riverside, CA, United States | 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 | |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | 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 | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzler Medizintechnik GmbH | Frittlingen Baden-Wurttemberg, Germany | Contract 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 | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| e.l. zepf GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medi-plus Instrumente GmbH | TUTTLINGEN-NENDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 15, 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.