BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994235923·INSTRUMENT 7080918 BALL TIP LOCK DRIVER

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000884550·INSTRUMENT 7080918 BALL TIP LOCK DRIVER

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608310·ALLEN, STERIS-AMSCO 5" SOFTCARE

    BONASTENT® Biliary

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369461221·

    ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code HAB·April 24, 2013

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 7, 2011

    UNKNOWN DEPUY PATELLA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·July 22, 2008

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014