Data / Medical devices / Tenaculum, Uterine
Tenaculum, Uterine (HDC): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Tenaculum, Uterine (product code HDC, Class 2, 21 CFR 884.4530). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on January 25, 2023, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HDC
- Device class
- 2
- Regulation
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| Pakistan | 5 |
| United States | 4 |
| Germany | 2 |
| Switzerland | 1 |
| Malaysia | 1 |
Makers of Tenaculum, Uterine
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspivix SA | Epalinges Vaud, Switzerland | Specification developer | 1 | January 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 1 | November 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Track Of Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 1 | March 17, 1998 | 0 | 0 | 0 | api.fda.gov |
| Bashir Jamil & Brothers (pvt.), Ltd. | Sialkot Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conqueror Medical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elmed Instruments (pvt). Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gimmi GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Asia Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, 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 |
Updated January 25, 2023. 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.