Data / Medical devices / Guide, Needle, Surgical / United States
FDA-registered makers of Guide, Needle, Surgical in the United States: 51 establishments
51 establishments in the United States are registered with the FDA to make Guide, Needle, Surgical (product code GDF). 1 has a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Guide, Needle, Surgical
- Product code
- GDF
- Country
- United States
Makers of Guide, Needle, Surgical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 1 | March 11, 1985 | 0 | 0 | 0 | api.fda.gov |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 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 | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avnet, Inc. (Avnet Logistics) | Chandler, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cinova Medical Inc. | Phoenix, AZ, United States | Contract 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 | |
| Elliquence LLC | Baldwin, NY, United States | Manufacturer, Specification developer | 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 | |
| Hologic, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumental Machine & Development, Inc. | Warsaw, IN, United States | Contract manufacturer | 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 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerylos Corporation | Reno, NV, United States | Specification developer | 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 | |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 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 Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 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 | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 1 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Needle Specialty Products | Boyle, MS, 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 | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pilotis Tech LLC | Brookhaven, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips DS North America LLC | Gainesville, FL, United States | Complaint file establishment, Specification developer | 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 | |
| Ridge & Crest Company | Monterey Park, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectra Medical Devices, LLC | Wilmington, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Usa (limited) LLC | Lakeland, FL, United States | Contract manufacturer | 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 | |
| Sureax Medical, Corporation | San Diego, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgentec LLC | Boca Raton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet, Inc. | Kenosha, WI, United States | Contract 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 | |
| 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 | |
| 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 | |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Repackager or relabeler, Specification developer | 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.