BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

    FDA Enforcement
    Class II ·Terminated·Wal Mart Stores, Inc·June 25, 2014

    PHYSICA PS TIBIAL LINER #4

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code JWH·November 23, 2020

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546567·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546536·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546529·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546574·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546543·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546550·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033546512·

    UROSCOPE, ARTES MEDICAL, USA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    PASSIVE PLUS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    MICROPLEX HYPERSOFT 10-SYSTEM COIL (MCS)

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·March 13, 2008

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 19, 2023

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024