BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    NEXUS DETACHABLE COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTEMPRO-MIST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KM-30 TENS ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Injury ·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 12, 2013

    LIFESTENT VASCULAR STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code NIP·March 15, 2011

    VICTORY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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