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

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    SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 28, 2016

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970733·anteriors; shade B4; mould IXL

    REAGENT SYSTEM, THYROXINE, ARIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ScanX Intraoral View

    FDA 510(k)
    FDA Class 2 ·Dental

    ENTERPRISE2 4MMX23MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·March 30, 2023

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·February 20, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 25, 2011

    DRILL ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWE·July 31, 2014

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Injury ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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