BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    EsoCheck Cell Collection Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD

    FDA UDI
    Medos International Sàrl·10886705028009·PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE...

    TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CELSIUS CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 2, 2022

    LASIK EYE SURGERY

    FDA Adverse Event
    Injury ·*·Product code LZS·October 27, 2008

    CONTOUR TEST STRIPD

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 15, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    HEALIX AV PK 5.5 TAPE WHT/BLUE

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL·Product code MBI·October 23, 2018

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026