BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704289503·

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00350770446295·MIC* Standard PEG Kit - Pull Method

    CEMPER

    FDA 510(k)
    FDA Class 2 ·Dental

    VIADERM

    FDA 510(k)
    FDA Unclassified ·Unknown

    70 DEG CURVED SUCTION, AXIEM¿

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 15, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·January 10, 2011

    MINIMAL ACCESS ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·December 13, 2013

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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