BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    VYDAX 525-550 & 5100 FLUOROTELOMER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACQSIM-MULTISLICE-CT, MODEL 453567042271

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHARRUAPACS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NANOTITE TM CERTAIN¿ PREVAIL¿ IMPLANT 4/5/4 X 8.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·May 26, 2023

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·May 14, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2012

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010

    Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·August 29, 2011

    Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product 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·September 22, 2011

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024