BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    LifeSPARC Pump, LifeSPARC Controller

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304673892·

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180175143·FAST RETRACTOR SWIVEL BLADE HOLDER-SHAFT ASSEMB...

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304647992·

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEWDEAL INTERPHALANGEAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    FDA Adverse Event
    Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·December 6, 2021

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 22, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011

    Quanta System Sterile Optical Laser Fiber, reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EYB·July 2, 2024

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·February 28, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code EZL·July 8, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·January 15, 2021

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017