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

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    TERFUSION FINAL FILTER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Couture Essence

    FDA UDI
    Carolon Company·00078301871032·

    Couture Essence

    FDA UDI
    Carolon Company·00078301810130·

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664825191·Reusable SpO2 Sensor/DIXTAL/Y-type Multi-site/A...

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127020292·Neck Trial, Size 13, Standard

    LASER MECHANISMS LASER SCANNING SYSTEM

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

    SEARS BEHIND-THE-EAR HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 25, 2020

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2025

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 31, 2012

    CONCERTO CRT-D DR AT

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·August 20, 2010

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017