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AESCULAP
AESCULAP, INC. · Model MG450R · UDI-DI 04046955057191
HDC
Prescription
10
510(k) clearances
47
Adverse events (1 deaths)
8
Recalls
22
Facilities
Description
HULKA TENACULUM FCPS 1 PRG & PROBE 280MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-10 | Stradis Medical, LLC dba Stradis Healthcare | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| 2021-09-10 | Stradis Medical, LLC dba Stradis Healthcare | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| 2021-09-10 | Stradis Medical, LLC dba Stradis Healthcare | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| 2021-09-10 | Stradis Medical, LLC dba Stradis Healthcare | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| 2021-09-10 | Stradis Medical, LLC dba Stradis Healthcare | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| 2021-09-10 | Stradis Medical, LLC dba Stradis Healthcare | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a |
| 2011-07-29 | GYN Disposables Inc | Lack of sterility assurance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.