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Instrument Tray, Mini
KATALYST SURGICAL LLC · Model 4600M · UDI-DI 00840096200560
HNJ
Prescription
3
510(k) clearances
12
Adverse events
1
Recalls
78
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-06-27 | Insight Instruments, Inc. | The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance. |
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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.