BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    ZENITH 40% PHOSPHORIC ACID GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    Penumbra System 3D Revascularization Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Injury ·AESCULAP INC·Product code KCT·October 12, 2016

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    ATLAS

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·October 27, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 30, 2012

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Malfunction ·AESCULAP INC·Product code KCT·July 26, 2016

    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