BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    UNITED UTF STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169601208·SPACER 2110245 OLIF25 20MM 0 DEG 10X45

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707097549·BKT 45 INTERACTIVE SL 22 T-17 A+2 BH

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    HS/HG PROSTHETIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTIVHEAL SCAR MANAGEMENT DRESSING

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

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 11, 2019

    STOPCOCK MANIFOLD GANGS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 13, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 23, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 20, 2011

    LINER #M FOR MOBILE LINER Ø40

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LZO·December 13, 2022

    Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025