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

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    Peel-Away Introducer

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

    Mouse anti-MDM2 (IF2) Concentrate

    FDA UDI
    LIFE TECHNOLOGIES CORPORATION·10190302000086·

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062029943·Rotary Files

    mambo™ modular cervical plate system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536008254·mambo caudal plate L blue

    MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 14, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·September 12, 2008

    INNOVA IGS 530

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019

    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