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

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    NuVasive VuePoint II OCT System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV

    ECG Module(AHA)

    FDA UDI
    SAMSUNG MEDISON CO., LTD.·08806167712532·

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304239951·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE

    VEINNOVATIONS INFILTRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W

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

    OSS 23CM DIAPHYSEAL SEGMENT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KRO·July 9, 2019

    OSS 23CM DIAPHYSEAL SEGMENT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KRO·July 9, 2019

    OSS 13CM TAPERED DIAPH SEGMENT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KRO·July 9, 2019

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 6, 2013

    COLLEAGUE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    CUSA EXCEL 23KHZ CEM NOSECONE

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·July 11, 2016

    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017