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

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    ARTHROLUX ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CODMAN® HOLTER®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780515524·CODMAN® HOLTER® Type A Fixation and Joining Con...

    CODMAN HOLTER

    FDA UDI
    Cerenovus, Inc.·10886704040736·CODMAN HOLTER Type A Fixation and Joining Conne...

    IMAGER II ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·November 6, 2012

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2015

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012