BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    CS 8100 CS 8100 ACCESS

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564031679·4-DRAPE SHEET PACK, 60X70

    LuxaCrown

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1209750·Self-curing Composite for the fabrication of se...

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00810019800993·Drape, Sheet, 56x80", 4-Pk

    NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENDURO MENISCAL COMPONENT F2 22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

    ENDURO MENISCAL COMPONENT F2 10MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 20, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    ACCU-CHEK ® INFORM BASE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·June 13, 2011

    ENDURO MENISCAL COMPONENT F1 10MM

    FDA Adverse Event
    Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

    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