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

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    AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486016814·Leg Positioner Disposables Kit

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026230·microSelectron Transfer Tube for 5F Flexibles (22)

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471158586·Cutanium 35° D-Form 016X022

    POLYFUSE - NEUROBONE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CALGITROL AG SILVER ALGINATE WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 6, 2013

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR SWITZERLAND·Product code FGE·August 13, 2008

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 2, 2011

    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

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021