BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OB TRIPP TRANSPORT CHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788231510·Pituitary, Up Biting, 3mm

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734021880·Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml

    Nu-beca Transcutaneous Electrical Nerve Stimulation

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDOSEE MODEL 8000 U-SCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 21, 2014

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 7, 2012

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·June 6, 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