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

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    INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551313824·Irrigation Tube for Handpiece

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011252612200·ceraMotion® Me 3D Dentin CC31, 20 g / dental ce...

    Vu ePOD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981048822·26mm Trial, 5 Deg, 12 mm

    DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    eSensor Warfarin Sensitivity Saliva Test

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NA

    FDA UDI
    Exactech, Inc.·10885862552198·TRIAL, TIBIAL SPACER, SIZE 0, 12 mm

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    IVT DISPOSABLES

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2013

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·January 10, 2012

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 10, 2012

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014