BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET

    FDA 510(k)
    FDA Unclassified ·Unknown

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450796900·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033570630·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033570685·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033570623·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033570678·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033570647·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033570654·

    COMPRESSIBLE LIMB SLEEVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·March 19, 2015

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 16, 2024

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 21, 2013

    TENDRIL SDX

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

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 13, 2008

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016