BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141076·15-20 MFW VITALITY CALF CT CHARC I

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201503072·Leksell MPS Arc w Counter Scale - ARC SUPPORT LEFT

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291105411·SS Suture, 8 per sleeve

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581014796·

    BLUEENDO

    FDA UDI
    TROKAMED GmbH·04251303822103·Trocar, conical blunt Ø 20 mm for protective sl...

    K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER

    FDA Adverse Event
    Malfunction ·Product code LXH·November 2, 2021

    K-WIRE GAMMA Ø3,2X450 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 22, 2022

    FIBIOCORE

    FDA 510(k)
    FDA Class 1 ·Dental

    LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT VASCULAR INTERVENTION·Product code MAF·August 10, 2006

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·August 10, 2006

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·April 3, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 5, 2011

    LIFELINE AED

    FDA Adverse Event
    Death ·DEFIBTECH, LLC·Product code MKJ·May 9, 2008

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024