Data / Medical devices / Staple, Fixation, Bone
Staple, Fixation, Bone (JDR): 157 FDA-registered makers in 11 countries
157 establishments in 11 countries are registered with the FDA to make Staple, Fixation, Bone (product code JDR, Class 2, 21 CFR 888.3030). 56 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 233 510(k) clearances under this code, the latest on September 1, 2026, and lists 18 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
- JDR
- Device class
- 2
- Regulation
- 888.3030
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 108 |
| Germany | 12 |
| France | 10 |
| Switzerland | 8 |
| United Kingdom | 5 |
| China | 5 |
| Malaysia | 3 |
| Finland | 2 |
| Mexico | 2 |
| Costa Rica | 1 |
| Taiwan | 1 |
Makers of Staple, Fixation, Bone
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 16 | June 29, 2007 | 0 | 1 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 13 | February 26, 2020 | 0 | 2 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 11 | October 2, 2015 | 0 | 2 | 0 | api.fda.gov |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Specification developer | 7 | February 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 6 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Complaint file establishment, Manufacturer, Specification developer | 6 | June 10, 2022 | 0 | 1 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 5 | June 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Medartis Inc. | Warsaw, IN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 5 | August 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Crossroads Extremity Systems LLC | Memphis, TN, United States | Manufacturer | 4 | August 16, 2019 | 0 | 1 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 4 | April 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | August 6, 2026 | 0 | 1 | 0 | api.fda.gov |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL, United States | Manufacturer | 4 | December 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 4 | May 7, 2021 | 0 | 1 | 0 | api.fda.gov |
| Medshape, Inc. | Atlanta, GA, United States | Complaint file establishment, Specification developer | 3 | August 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 3 | April 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer, Manufacturer for export | 3 | May 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biopro, Inc. | Port Huron, MI, United States | Manufacturer | 2 | October 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| In2Bones SAS | Saint-Priest Rhone, France | Exporter to the US, Specification developer | 2 | March 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 2 | June 4, 1993 | 0 | 0 | 0 | api.fda.gov |
| Novastep | RENNES Bretagne, France | Manufacturer | 2 | December 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer | 2 | July 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| RMR ORTHO, Inc | San Antonio, TX, United States | Complaint file establishment, Specification developer | 2 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 2 | April 3, 2000 | 0 | 1 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 2 | May 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 2 | August 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 2 | August 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Vilex LLC | Mcminnville, TN, United States | Manufacturer | 2 | August 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Xiros Ltd | YEADON Leeds, United Kingdom | Manufacturer | 2 | July 13, 2001 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 1 | October 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 1 | February 1, 1995 | 0 | 0 | 0 | api.fda.gov |
| Arthrocare Corporation | Coyol Alajuela, Costa Rica | Manufacturer | 1 | April 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer | 1 | July 10, 1996 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 1 | May 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Exotoe LLC | Charlotte, NC, United States | Manufacturer, Specification developer | 1 | January 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Extremity Medical, LLC | Parsippany, NJ, United States | Specification developer | 1 | December 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| F & A Foundation | Tulsa, OK, United States | Specification developer | 1 | April 6, 2018 | 0 | 1 | 0 | api.fda.gov |
| Fusion Orthopedics Usa, LLC | Mesa, AZ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | October 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| GLW Europe GmbH | Wurmlingen Baden-Wurttemberg, Germany | Specification developer | 1 | December 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gramercy Extremity Orthopedics, LLC. | Richardson, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| In2bones Usa, LLC | Cordova, TN, United States | Manufacturer, Specification developer | 1 | October 24, 2016 | 0 | 2 | 0 | api.fda.gov |
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | April 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | April 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medartis AG | BASEL Basel-Stadt, Switzerland | Manufacturer | 1 | August 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 1 | October 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Merete GMBH | Berlin, Germany | Specification developer | 1 | December 28, 2015 | 0 | 1 | 0 | api.fda.gov |
| Metric Medical Devices, Inc. | Helotes, TX, United States | Manufacturer, Specification developer | 1 | January 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Nvision Biomedical Technologies, Inc | San Antonio, TX, United States | Repackager or relabeler, Specification developer | 1 | April 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ortho Solutions UK Limited | Maldon Essex, United Kingdom | Complaint file establishment, Manufacturer, Specification developer | 1 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | May 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Manufacturer, Specification developer | 1 | March 13, 1997 | 0 | 0 | 0 | api.fda.gov |
| Trax Surgical, Inc. | Stoughton, MA, United States | Manufacturer | 1 | May 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Trimed, Inc. | Santa Clarita, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 1, 2019 | 0 | 1 | 0 | api.fda.gov |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 1 | October 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| XL Precision Technologies Ltd | Stockton on Tees Stockton-on-Tees, United Kingdom | Contract manufacturer, Exporter to the US | 1 | November 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| Almark Tool & Manufacturing Company, Inc. | Garwood, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMF, Sarl | Lury sur Arnon Cher, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arcamed, LLC | Indianapolis, IN, 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 | |
| Arctic Biomaterials OY | Tampere Pirkanmaa, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Plymouth, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Automatics Tooling Company Ltd | Salfords Surrey, United Kingdom | Contract 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 | |
| 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, 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 | |
| B & J Medical LLC | Kendallville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIEDERMANN MOTECH GMBH & Co. KG | VS-SCHWENNINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biocomposites Ltd. | Keele Staffordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blaze Biotech, LLC | San Antonio, TX, United States | 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 | |
| Conextions Inc | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eca Medical Instruments | Newbury Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forecreu | Malicorne Allier, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Sino-Mim Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hermann Medizintechnik GMBH | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HG Medical Usa, LLC | Holland, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HG Medical GmbH | Raisting Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrity Systems | Olive Branch, MS, United States | Contract 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 | |
| Janco, Inc. | Rollinsford, NH, 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 | |
| Kapstone Manufacturing | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kingj Medical Co., Ltd | Zhangjiagang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifestyle Medical Manufacturing | Logan, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mach Medical | Columbia City, IN, 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 | |
| Marle Finishing SAS | La Talaudiere Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Matrix Machining Technologies, Inc. | Memphis, TN, United States | Contract 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 Component Specialists | Bellingham, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicatechnologie | CHARTRES-DE-BRETAGNE Ille-et-Vilaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medin Technologies, Inc. | Totowa, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech LLC | Millington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miing Wei Co., Ltd. | Tsao-Twon Nantou, Taiwan | Contract 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 | |
| MK medical GmbH | Emmingen-Liptingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount MFG | Marquette, MI, 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 | |
| Onyx Medical LLC | Memphis, TN, 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 | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peridot Corporation | Pleasanton, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Medical Products, Inc. | Mountain City, TN, United States | 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 | |
| Precision Medical Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies | Rome City, IN, 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 Inc. | Castleton, IN, 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 | |
| Precision Edge Surgical Products Co LLC | Boyne City, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products, LLC | Angola, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, 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 | |
| Rapharin | GENAS Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Red Star Contract Manufacturing Inc. | Larwill, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Responsive Arthroscopy | Minneapolis, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ruetschi Technology AG | Muntelier Fribourg, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resonetics, LLC | Bethel, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seaway Plastics Engineering, LLC | Brooksville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Selenium Medical S.A.S. | La Rochelle Charente-Maritime, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simagec | ROUSSET CEDEX Bouches-du-Rhone, France | 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 Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Trauma GMBH | SCHOENKIRCHEN Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract manufacturer | 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 | |
| Spectrum Plastics Group | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tesco Associates, Inc. | Tyngsboro, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, 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 | |
| TranS1 | Magnolia, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trilliant Surgical LLC | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VCN Technologies | SAINT-PRIEST Auvergne-Rhone-Alpes, 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 | |
| Z-Medical GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 1, 2026. 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.