Data / Medical devices / Instrument, Manual, General Obstetric-Gynecologic / United States
FDA-registered makers of Instrument, Manual, General Obstetric-Gynecologic in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Instrument, Manual, General Obstetric-Gynecologic (product code KOH). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Instrument, Manual, General Obstetric-Gynecologic
- Product code
- KOH
- Country
- United States
Makers of Instrument, Manual, General Obstetric-Gynecologic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ceek Women's Health | Portland, OR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geotec, Inc. | Warwick, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer, Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Manufacturing LLC | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Ltd. | Devens, MA, 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 | |
| Surgin Surgical Instrumentation, Inc. | Scottsdale, AZ, United States | Repackager or relabeler, 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 |
Updated November 3, 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.