BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517631206·CoRoent Ant TLIF Ti, 14x11x32mm 12°

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707040439·DB BRACKETS 22 T-2 A+13 BH CUS U/R

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517084795·

    VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE 02.12.E0412FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 4, 2023

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 10, 2014

    POSEY KEEPSAFE DELUXE ALARM

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 2, 2011

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 22, 2013

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·November 20, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·December 19, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 8, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 22, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·January 26, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·February 12, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    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