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

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    LIPO CANNULA

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

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609119·SKYTRON 2" STANDARD

    CD123-PE

    FDA UDI
    Miltenyi Biotec B.V. & Co. KG·04049934134203·AC145 recognizes human CD123, also known as IL-...

    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

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·July 12, 2017

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 2, 2017

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 14, 2011

    PIC

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·July 18, 2008

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    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

    AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

    HOSP SS FLEXX METER W/O LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Death ·LIFESCAN INC.·Product code NBW·April 1, 2011

    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

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021