BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Packout-5 - Class A First Aid Kit - Poly

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588226378·Packout-5 - Class A First Aid Kit - Poly

    DYNAREX ULTRASOUND GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 30, 2021

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 21, 2013

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 26, 2014

    PFC SIGMARP STB TB IN 4 10.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·June 3, 2011

    CENTRIMAG BLOOD PUMP

    FDA Adverse Event
    Injury ·THORATEC SWITZERLAND GMBH·Product code QNR·May 5, 2025

    CENTRIMAG BLOOD PUMP

    FDA Adverse Event
    Injury ·THORATEC SWITZERLAND GMBH·Product code DSQ·February 7, 2025

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·December 18, 2023

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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