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Richard Wolf GmbH · Model 82405 · UDI-DI 04055207008140
10
510(k) clearances
98
Adverse events (7 deaths)
8
Recalls
33
Facilities
Description
NEEDLE ELECTRODE MONO 5FR WL 420MM for cystoscopy, electrode shape: needle, PACK=1 PC, reusable
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.