BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    SWR DISPOSABLE PREP RAZOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MSI

    FDA UDI
    Modern Surgical Instruments LLC·B4198101120·

    Cabo™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508101246·1 LEVEL PLATE 12mm

    Cabo

    FDA UDI
    Seaspine Orthopedics Corporation·10889981079345·2 Level Cervical Plate 12mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101120·Distractor, Smooth Paddle, Lordotic, 12mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312L0101120·Distractor, Smooth Paddle, 12mm

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127020285·Neck Trial, Size 12, Standard

    Obturator

    FDA UDI
    SOPRO-COMEG GmbH·04059082031620·

    BIPOLAR COAGULATION SYSTEM

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

    CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414640380·Automatic Disposable Biopsy Needle

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2020

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 1, 2015

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·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