BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    THERMAL-PAK MODEL SW 1000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575255757·Articulating Surfaces, PS

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575255719·Articulating Surfaces, PS

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575255696·Articulating Surfaces, PS

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575255733·Articulating Surfaces, PS

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575255726·Articulating Surfaces, PS

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575255702·Articulating Surfaces, PS

    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code MZP·December 19, 2012

    OPTIVANTAGE WITH PEDESTAL

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·October 19, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014

    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017