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

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    Bigfoot Unity® Diabetes Management System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569813·CoRoent Ant TLIF Ti, 12x12x28mm 0°

    HEALIX TRANSTEND ORTHOCORD PERCANNULA

    FDA UDI
    Medos International Sàrl·10886705020324·HEALIX TRANSTEND(PEEK/2) IMPLANT SYSTEM (2) PEE...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111121081·ROCH-PEAN FCP DEL CVD 8

    STOCKERT CORONARY PERFUSION CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 12, 2013

    STOCKERT CORONARY PERFUSION CANNULAE

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

    DREAMSTATION AUTO BIPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·January 5, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014