BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    VASCU-GUARD Peripheral Vascular Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRACTORA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    ARROW-LOK DIGITAL FUSION SYSTEM

    FDA Adverse Event
    Injury ·ARROWHEAD MEDICAL DEVICE TECHNOLOGIES·Product code HTY·March 28, 2013

    M POWER PRO 6202

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC HALL·Product code HWE·June 22, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 5, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015