BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BioFire Blood Culture Identification 2 (BCID2) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET

    FDA 510(k)
    FDA Unclassified ·Unknown

    9680515-2008-00011

    FDA Adverse Event
    Other ·Product code HTX·January 8, 2009

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·November 8, 2010

    VENTRALIGHT ST WITH ECHO

    FDA Adverse Event
    Malfunction ·DAVOL INC SUB C.R. BARD, INC.·Product code FTL·February 14, 2014

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012