BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    CARDIOPULMONARY BYPASS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023871·BAYONETTED STRAIGHT RING CURETTE

    Tono Vue Non-Contact Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM

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

    ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880

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

    M2A-38 CUP NON FLARED SZ 56MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    DUAL CHAMBER TEMPORARY PACEMAKER

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD·Product code DTE·June 26, 2019

    DUAL CHAMBER TEMPORARY PACEMAKER

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD·Product code DTE·July 12, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    PULSE GEN

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 29, 2008

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018