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Hayden Medical

Hayden Medical, Inc. · Model 405-465CS · UDI-DI 00840319758991

FWF Prescription
10
510(k) clearances
288
Adverse events
2
Recalls
50
Facilities

Description

Endoscopic Camera System and Light Source, Full HD 1080P Resolution with white balancing, zoom, and image capture. 2.3 Pro Camera head, 11 surgery modes, improved color, stroboscopic surgery Includes: Camera Head, Fiber Optic Light Cable

Recalls

DateFirmReason
2007-01-19Smith & Nephew, Inc Endoscopy DivisionSurgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
2007-01-19Smith & Nephew, Inc Endoscopy DivisionSurgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

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Data 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.