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

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    KOWA, FM-600, MODEL LSS50

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450225806·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450399149·

    Orthopedic Instruments

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258660967·

    THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OMNILINK .018 BILIARY STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    1049092-2018-00287

    FDA Adverse Event
    Injury ·Product code FRO·May 15, 2018

    9618003-2021-01239

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.

    FDA Enforcement
    Class III ·Terminated·Abbott Point Of Care Inc.·November 14, 2012

    V SERIES MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    SECURE 2 MED/SURGBED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 11, 2011

    Dressing, wound, drug

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021

    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JJT·July 19, 2012

    9618003-2021-01006

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021

    HAH TAPERED IMPLANT 4.3 X 10MM

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 13, 2022

    9618003-2021-01210

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

    HAHN TAPERED IMPLANT 4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 19, 2022

    Dressing, wound, drug

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·October 17, 2022

    9618003-2022-00003

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·January 6, 2022