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

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    Lavieen

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

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996181044·24Lx14H-6 DEG, TRIAL, TI SHARK TL

    NEWPORT C250 AIR COMPRESSOR MODEL C250

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    S-ROM M HEAD 36MM +3

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JDI·September 9, 2011

    GYNECARE TVT SECUR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·July 22, 2013

    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·March 29, 2017

    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