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Strauss Surgical
AMERICAN MEDICAL ENDOSCOPY, INC. · Model STS-ACC-5000-CAPD-000 · UDI-DI 00851925007359
10
510(k) clearances
96
Adverse events (7 deaths)
8
Recalls
33
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-07-23 | Karl Storz Endoscopy | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
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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.