BEUDAMED
    11 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    KARL STORZ VIDEO GASTROSCOPES

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

    LITE SEMI-TUBULAR PLATE, 7-HOLE

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665031676·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank

    STACKED ABR FOR NAVIGATOR PRO

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC.·Product code GJS·April 10, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 14, 2011

    MCROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM

    FDA Adverse Event
    Injury ·MICROSULIS MEDICAL LTD.·Product code MNB·June 13, 2008

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011