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

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    GaltTWS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741826600·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674182660060·

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·August 24, 2015

    V60 VENTILATOR, MODEL V8000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    HUDSON LIFESAVER RESUSCITATION BAG (INFANT)

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTM·July 1, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

    PILLOW, GEL INFANT POSITIONING AID 6INX9IN

    FDA Adverse Event
    Malfunction ·HAWAII MEDICAL, LLC·Product code FRP·September 21, 2008

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·October 24, 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