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EVONOS GMBH & Co. Kg
Gyrus ACMI, LLC · Model 130665 · UDI-DI 00821925014398
EPY
Prescription
10
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities
Description
EAR SURGERY SPECULUM ROUND 6.5MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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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.