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

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    RF-IVD WIRELESS DOSIMETER-MODEL 1133

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H69510113321·Surgical Paper Tape

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890113320·Zirlux Angled Multi-Unit Abutment Screw compati...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810113321·Surgical Paper Tape

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033280096·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033280126·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033280119·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033280102·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve

    WAKO IMMUNOASSAY CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 25, 1998

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 9, 1998

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·March 19, 2013

    UNKNOWN DEPUY ASR RESURFACING HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

    AEROSET ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·March 11, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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