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ENDOPRO-MDTK
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model EP-MDTK · UDI-DI 00848657076937
10
510(k) clearances
288
Adverse events
2
Recalls
50
Facilities
Description
Monostereo 3D Video System Enhancement
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-01-19 | Smith & Nephew, Inc Endoscopy Division | Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT) |
| 2007-01-19 | Smith & Nephew, Inc Endoscopy Division | Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT) |
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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.