Data / Medical devices / Probe And Director, Gastro-Urology / United States
FDA-registered makers of Probe And Director, Gastro-Urology in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Probe And Director, Gastro-Urology (product code FGM). 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
- Probe And Director, Gastro-Urology
- Product code
- FGM
- Country
- United States
Makers of Probe And Director, Gastro-Urology in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bear-Ent, LLC | Malvern, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, 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 | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS-Martin L.P. | Jacksonville, FL, United States | 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 | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical | Philadelphia, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | 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 | |
| Weco Manufacturing Group-Henrietta | Rochester, NY, 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.