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

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    ANTI-LEU-12 B CELL REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209101801·KIT, SLING PACK MED

    Auxillary

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746056352·DOUBLE UP VERTICAL AUXILLARY 018/018 10/PKG

    ABL80 FLEX and ABL80 FLEX CO-OX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PSI SD800.430 PEEK IMPLANT

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code GXN·June 5, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 29, 2012

    ALARIS ADMINISTRATION SET

    FDA Adverse Event
    Injury ·CAREFUSION CORPORATION·Product code FPA·September 29, 2010

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 3, 2012

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 12, 2015

    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