BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    CERAMIN BRACKETS Z

    FDA 510(k)
    FDA Class 2 ·Dental

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197522045·CeraCut Stevens Tenotomy Scissors curved blunt...

    BD K-4000 MICROKERATOME SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ZIMMER CONTOUR PROVISIONAL COPING

    FDA 510(k)
    FDA Class 2 ·Dental

    EVOLIS CEMENTED FIXED FEMUR SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·November 14, 2014

    ON-X MITRAL PROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·December 8, 2008

    VALIANT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·May 21, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·September 21, 2023

    Brilliance 64 728232 Computed Tomography 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 Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016

    Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 8, 2016

    Philips Brilliance 64 computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems·October 12, 2016

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022