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USA Elite
Gyrus ACMI, LLC · Model K-HB · UDI-DI 00821925002647
EZO
Prescription
5
510(k) clearances
69
Adverse events
1
Recalls
37
Facilities
Description
USA Elite System and USA Series Cold Knife, Hook Blade (3/PK)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-22 | Olympus America Inc. | The device sterile package seal shows evidence of being breached or was breached |
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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.