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Hayden Medical
Hayden Medical, Inc. · Model 405-465 · UDI-DI 00840319757956
FWF
Prescription
10
510(k) clearances
288
Adverse events
2
Recalls
50
Facilities
Description
Pro Slim Endoscopy Video unit and light source, Full HD 1080P Resolution, Fiber Optic Light Cable, footswitch, USB Drive and Power Cable
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.