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

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    Longterm NPWT Foam Dressing Kit

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

    4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    P3T ABDOMEN

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

    COLLEAGUE PRE P1.7

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

    9600

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

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    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