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

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    TORNIER ELBOW PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRYVIEW DVB Laser Imaging Film

    FDA UDI
    CARESTREAM HEALTH, INC.·40889971050843·125SH 35X43CM DVB (2PK) CE

    NAFD 100

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

    TDK HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 10, 2013

    TW POWER SUPPLY, US

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code HQO·April 1, 2011

    RIATA PASSIVE FIXATION LEAD

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

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    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