BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    SPEEDLYSER INFUSION CATHETER KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033443·Baltic Denture System BDLoad BDLoad ↓ Mw7 PLSEu...

    SUCTION IRRIGATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

    FDA Adverse Event
    Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

    VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

    FDA Adverse Event
    Injury ·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    FDA Adverse Event
    Malfunction ·ETHICON, INC·Product code GAM·April 3, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 23, 2011

    DAMON COPPER NITI WIRE

    FDA Adverse Event
    Malfunction ·ORMCO CORP.·Product code DZC·April 23, 2008

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·April 13, 2016

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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