BEUDAMED
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    EL2-SERIES BLOOD COLLECTION REERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLES FRACTURE FRAME

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·January 25, 2013

    VISIONAIRE

    FDA Adverse Event
    Malfunction ·AIRSEP CORP.·Product code CAW·November 22, 2010

    5MM MONOPOLAR HANDLE 33CM

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·July 11, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016