Data / Medical devices / Blade, Saw, General & Plastic Surgery, Surgical / United States
FDA-registered makers of Blade, Saw, General & Plastic Surgery, Surgical in the United States: 92 establishments
92 establishments in the United States are registered with the FDA to make Blade, Saw, General & Plastic Surgery, Surgical (product code GFA). 4 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Blade, Saw, General & Plastic Surgery, Surgical
- Product code
- GFA
- Country
- United States
Makers of Blade, Saw, General & Plastic Surgery, Surgical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Manufacturer | 1 | October 14, 1986 | 0 | 0 | 0 | api.fda.gov |
| Kirwan Surgical Products, LLC. | Marshfield, MA, United States | Manufacturer | 1 | May 30, 1986 | 0 | 0 | 0 | api.fda.gov |
| Microport Orthopedics Inc. | Arlington, TN, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | January 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer | 1 | February 24, 1994 | 0 | 2 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | 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 & M Precision, Inc. | Ruskin, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bestway Products | Gardena, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | 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 | |
| Chapman Lake Instrument | Bloomington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadence Inc. | Staunton, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D & R Products Co., Inc. | Hudson, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DT Medtech LLC | McMinnville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eca Medical Instruments | Newbury Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exactech, Inc. | Gainesville, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace Manufacturing Inc | Russellville, AR, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gramercy Extremity Orthopedics, LLC. | Richardson, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 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 | |
| LAB Medical Manufacturing, Inc. | Billerica, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lighthouse Tech | Chandler, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Manufacturer, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medartis Inc. | Warsaw, IN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 1 | 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 | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuell, Inc. | Leesburg, IN, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omega Surgical Instruments, Inc. | Flint, MI, United States | Repackager or relabeler, Specification developer | 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 | |
| Orthopedic Sciences, Inc | Overland Park, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomed | Addison, TX, United States | Manufacturer, Repackager or relabeler, 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 | |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Instruments Inc. | Honolulu, HI, United States | Contract 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 | |
| Phoenix Instruments, Inc. | Lisle, IL, 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 | |
| Putnam Precision Products, Inc. | Brewster, NY, 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 | |
| Renovo, Inc. | Bend, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ridge & Crest Company | Monterey Park, CA, United States | Manufacturer, Specification developer | 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 | |
| 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. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suretek Medical | Greenville, SC, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer, 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 | |
| SportCare | Hidalgo, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet, Inc. | Kenosha, WI, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Anspach Effort, Inc. | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 | |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL, United States | 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 | |
| Tritex Medical Manufacturing LLC | Mount Morris, MI, United States | Contract manufacturer, 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 | |
| Velocity Orthopedics, Inc. | Rancho Cucamonga, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vilex LLC | Mcminnville, TN, 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 | |
| X40 Tech | La Jolla, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Surgical, Inc. | Dover, OH, United States | Manufacturer, 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 |
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.