Data / Medical devices / Instrument, Surgical, Non-Powered / United States
FDA-registered makers of Instrument, Surgical, Non-Powered in the United States: 64 establishments
64 establishments in the United States are registered with the FDA to make Instrument, Surgical, Non-Powered (product code HAO). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Instrument, Surgical, Non-Powered
- Product code
- HAO
- Country
- United States
Makers of Instrument, Surgical, Non-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acra Cut, Inc. | Acton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ad-Tech Medical Instrument Corp. | Oak Creek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anchor Products Co. | Addison, IL, United States | 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 | |
| Artfx Medical LLC | Jax, FL, United States | Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Plano, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Black Forest Medical North America, Inc. | Cape Coral, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Checkpoint Surgical Inc. | Brecksville, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Checkpoint Surgical Inc. | Independence, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, 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 | |
| Fetzer Surgical, LLC | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FHC, Inc. | Bowdoin, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fischer Surgical Inc. | Imperial, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GLW, Inc. | Englewood Cliffs, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inspire Medical Systems Inc | Golden Valley, MN, United States | Complaint file establishment, 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, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katalyst Surgical, LLC | Chesterfield, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kirwan Surgical Products, LLC. | Marshfield, MA, United States | 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 | |
| LivaNova USA, Inc. | Houston, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Logan Instruments, LLC | Braintree, MA, United States | 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 | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mizuho America, Inc. | Union City, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monteris Medical Corp | Minnetonka, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurgain Technologies | La Jolla, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuroenterprises LLC | Chicago, IL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nico Corporation | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omt, LLC | Fort Lauderdale, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OPS Center (for Mobia Medical Inc.) | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthofix Us LLC | Lewisville, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathway Medtech, LLC. | Santee, CA, 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 | |
| PMT Corp. | Chanhassen, MN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, 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 | |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 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 | |
| Tecomet, Inc. | Kenosha, WI, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Troy Innovative Instruments Co LLC | Middlefield, OH, 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 | |
| Valencia Technologies Corporation | Valencia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| West Coast Surgical LLC. | Half Moon Bay, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| West Coast Surgical LLC | Houston, TX, 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.