BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MEDLITE C1 Q-SWITCHED ND:YAG LASER

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

    CT LUCIA

    FDA UDI
    CARL ZEISS MEDITEC PRODUCTION, LLC·00843045101178·3-piece, monofocal, hydrophobic, acrylic, intra...

    MACROPOREMX MANDIBULAR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BECKMAN COULTER DNASE B CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·November 3, 2006

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 10, 2013

    SECURA VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 12, 2011

    ATLAS + HF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 27, 2008

    ZILVER 518 SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 2012

    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