BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALLON 2001 MODIFIED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOTORIZED MICRO MULTILEAF COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 4, 2025

    IDRIVE ULTRA POWERED HANDLE 1

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY REGISTERED AS US SUR·Product code GDW·April 2, 2014

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·March 28, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011

    MODULAR MICROPLASTY CUP INSERTER

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code LXH·April 15, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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