BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    AI-Rad Companion (Musculoskeletal)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD

    FDA UDI
    Medos International Sàrl·10886705027811·TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue ...

    BD Difco™ Haemophilus Influenzae Antiserum Type b

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902223610·BD Difco™ Haemophilus Influenzae Antiserum Type...

    T:CONNECT DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UltraSlim Digital, UltraSmooth Digital

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014

    TRIMA ACCEL PLT, PLS, RBC SET

    FDA Adverse Event
    Other ·CARIDIANBCT·Product code LKN·August 19, 2011

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code FPA·July 12, 2013

    HEALIX AV BR 5.5 TAPE BLUE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code MAI·October 4, 2018

    HEALIX AV BR 5.5 TAPE BLUE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code MAI·September 21, 2018

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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