Data / Medical devices / Plate, Fixation, Bone / United States
FDA-registered makers of Plate, Fixation, Bone in the United States: 238 establishments
238 establishments in the United States are registered with the FDA to make Plate, Fixation, Bone (product code HRS). 80 have a 510(k) clearance or PMA approval on file and 24 have a recall event. FDA data exported November 2, 2026.
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- Device
- Plate, Fixation, Bone
- Product code
- HRS
- Country
- United States
Makers of Plate, Fixation, Bone in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 137 | March 10, 2026 | 0 | 9 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 65 | July 25, 2025 | 0 | 10 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 49 | June 6, 2019 | 0 | 9 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer, Manufacturer for export | 48 | June 6, 2019 | 0 | 3 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Manufacturer, Specification developer | 47 | March 3, 2026 | 0 | 3 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 43 | February 19, 2025 | 0 | 11 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 34 | February 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medartis Inc. | Warsaw, IN, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 28 | June 5, 2026 | 0 | 2 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 26 | June 2, 2026 | 0 | 2 | 0 | api.fda.gov |
| Trimed, Inc. | Santa Clarita, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 26 | July 16, 2026 | 0 | 6 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 25 | January 28, 2016 | 0 | 11 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer, Specification developer | 22 | July 14, 2025 | 0 | 6 | 0 | api.fda.gov |
| Skeletal Dynamics, Inc | Miami, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 19 | March 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 19 | July 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 18 | July 17, 2019 | 0 | 5 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 17 | February 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 16 | June 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 15 | April 30, 2026 | 0 | 4 | 0 | api.fda.gov |
| In2bones Usa, LLC | Cordova, TN, United States | Manufacturer, Repackager or relabeler, Specification developer | 13 | May 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 11 | July 18, 2025 | 0 | 1 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Manufacturer for export, Repackager or relabeler, Specification developer | 10 | April 20, 2021 | 0 | 1 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 9 | February 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL, United States | Manufacturer | 9 | September 15, 2026 | 0 | 1 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 8 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Orthopedic Sciences, Inc | Overland Park, KS, United States | Manufacturer, Specification developer | 8 | August 21, 2007 | 0 | 0 | 0 | api.fda.gov |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 8 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 8 | June 12, 2026 | 0 | 2 | 0 | api.fda.gov |
| Zimmer Manufacturing B.V. | Mercedita, PR, United States | Manufacturer | 8 | March 4, 2015 | 0 | 1 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 7 | April 3, 2015 | 0 | 0 | 0 | api.fda.gov |
| Crossroads Extremity Systems LLC | Memphis, TN, United States | Complaint file establishment, Manufacturer | 7 | January 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 7 | January 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 7 | June 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| The Orthopaedic Implant Company | Reno, NV, United States | Specification developer | 7 | October 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eagle Medical Packaging Sterilization, Inc. | Paso Robles, CA, United States | Contract manufacturer, Repackager or relabeler | 6 | January 4, 2011 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 6 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Orthonovis, Inc. | Palm Coast, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 6 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| S2ortho, LLC | Yardley, PA, United States | Specification developer | 6 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 5 | July 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Extremity Medical, LLC | Parsippany, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 5 | June 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower | Horsham, PA, United States | Specification developer | 4 | March 27, 2014 | 0 | 2 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 4 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| 4web Inc. | Frisco, TX, United States | Specification developer | 3 | May 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Arthrosurface, Inc. | W Bridgewater, MA, United States | Manufacturer | 3 | February 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Able Medical Devices | Marquette, MI, United States | Manufacturer | 3 | December 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Fusion Orthopedics Usa, LLC | Mesa, AZ, United States | Complaint file establishment, Specification developer | 3 | March 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 3 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Gramercy Extremity Orthopedics, LLC. | Richardson, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 21, 2021 | 0 | 1 | 0 | api.fda.gov |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 3 | May 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Nvision Biomedical Technologies, Inc | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| OsteoCentric Technologies,Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 3 | August 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Trilliant Surgical LLC | Houston, TX, United States | Manufacturer | 3 | February 23, 2022 | 0 | 2 | 0 | api.fda.gov |
| Avanti Orthopaedics LLC | Penn Valley, PA, United States | Complaint file establishment, Specification developer | 2 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC -Brookwood Facility | Hillsboro, OR, United States | Manufacturer | 2 | July 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fusion Innovations | Maitland, FL, United States | Specification developer | 2 | November 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Graham Medical Technologies, L.L.C. d.b.a. GraMedica | Rochester, MI, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | January 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| HyperFlex Medical Inc | Richmond, UT, United States | Specification developer | 2 | December 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 2 | July 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Contract manufacturer, Manufacturer | 2 | April 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Toby Orthopaedics | Miami, FL, United States | Manufacturer | 2 | November 4, 2013 | 0 | 1 | 0 | api.fda.gov |
| Vilex LLC | Mcminnville, TN, United States | Manufacturer | 2 | April 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer, Manufacturer | 1 | June 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 1 | July 26, 1991 | 0 | 0 | 0 | api.fda.gov |
| Chest Wall Innovations, Inc. | Hummelstown, PA, United States | Specification developer | 1 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 1 | August 31, 1998 | 0 | 2 | 0 | api.fda.gov |
| Endeavor Orthopaedics, Inc. | Tulsa, OK, United States | Complaint file establishment, Specification developer | 1 | July 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Exactech Sarasota | Sarasota, FL, United States | Manufacturer | 1 | May 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| Forma Medical, Inc. | Camp Hill, PA, United States | Specification developer | 1 | June 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| GLW, Inc. | Englewood Cliffs, NJ, United States | Complaint file establishment, Specification developer | 1 | March 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer, Manufacturer | 1 | November 26, 2014 | 0 | 0 | 0 | api.fda.gov |
| Kinamed, Inc. | Camarillo, CA, United States | Manufacturer | 1 | January 16, 1997 | 0 | 0 | 0 | api.fda.gov |
| Leith Medical LLC | Austin, TX, United States | Manufacturer | 1 | February 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Mcginley Orthopaedic Innovations, Inc | Casper, WY, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | June 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 1 | December 17, 1992 | 0 | 0 | 0 | api.fda.gov |
| Mirus, LLC | Marietta, GA, United States | Manufacturer | 1 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Netbiologics LLC | Lakewood Ranch, FL, United States | Manufacturer | 1 | July 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Manufacturer | 1 | August 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sky Surgical | Parkville, MO, United States | Complaint file establishment, Specification developer | 1 | December 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 1 | December 17, 1992 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 1 | December 17, 1992 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Trabecular Metal Technology, Inc. | Parsippany, NJ, United States | Manufacturer | 1 | April 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alden Tool Company, Inc. | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alto Development Corp. | Farmingdale, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Manufacturing And Engineering | Montgomeryville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arc Precision | Isanti, MN, United States | Contract 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 - Philadelphia, LLC Dba Jade Precision Medical Components | Huntingdon Valley, PA, United States | Contract 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 - 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 | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Artifex Solutions, LLC | San Juan, PR, United States | 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 | |
| Avalign Integrated Medical Solutions, Inc | Mentor, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acero Precision | West Chester, PA, United States | 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 | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Additive / Slice Manufacturing Studios | Akron, OH, United States | Contract 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 & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & J Medical LLC | Kendallville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioplate, Inc. | Placentia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | 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 | |
| CB Enterprises | Canyon Country, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 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 | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, 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 | |
| Eminent Spine, LLC | Plano, TX, 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 | |
| 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 | |
| Elite Medical, LLC | Cordova, TN, 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 | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, 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 | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fruh Packaging Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Machine, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardian Medical Usa, Inc | Swanton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | 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 | |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | 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 | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, 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 | |
| Jatex, Inc. | Nappanee, IN, 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 Inc. (Wilson Drive) | W Chester, PA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, 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 | |
| Lacey Manufacturing Company LLC | Bridgeport, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical LLC | Vandalia, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | 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 | |
| Matrix Machining Technologies, Inc. | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maxkron Machine, LLC | Valencia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Device And Implants LLC | Lancaster, PA, United States | 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 | |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | 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 | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount MFG | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MSK Precision Products, Inc. | Tamarac, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maestro Logistics, LLC | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MedCAD | Plano, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mendell | Lakeville, MN, United States | Contract 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 | |
| Microcision LLC | Pennsauken, NJ, 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 | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norman Noble, Inc. | Highland Heights, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NuVasive Specialized Orthopedics, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Odyssey Medical Technologies, LLC | Bartlett, TN, 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 | |
| Ortho Development Corp. | Draper, UT, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, 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 | |
| Precision One Medical | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulse Technologies, Inc. | Quakertown, PA, United States | 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 | |
| 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 | |
| Precision One Medical | Hoover, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quadm Technologies, LLC | Hamilton, NJ, 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 | |
| Ram Precision Industries Inc | Dayton, OH, 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 | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RevZero, Inc. | Chanhassen, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCT, Inc. | Franklin Lakes, NJ, United States | 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 | |
| Skeletal Dynamics Strategic Manufacturing Center | Bonita Springs, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Usa (limited) LLC | Lakeland, FL, United States | 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 | Contract manufacturer, 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 | |
| Surgtech, Inc. | Westlake, OH, United States | Manufacturer, Specification developer | 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, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sites Medical, LLC | Columbia City, IN, United States | Contract 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 | |
| Summit Orthopedic Technologies Inc. | Naples, FL, United States | Contract manufacturer | 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 | |
| Tecomet | Woburn, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tigon Medical LLC | Millersville, MD, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOMZ Corporation | Berlin, CT, 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 | |
| Tech Industries. Inc. | Cleveland, OH, 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 | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Universal Punch Corp. | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 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 | Orchard Park, NY, 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 | |
| Westwood Precision LLC | Allentown, PA, United States | Contract 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 November 2, 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.