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

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    TD TRICYCLIC ANTIDEPRESSANTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209115587·

    BRACE-UP ALL PURPOSE WRIST BAND

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDLINE MOSKAL TOTAL HIP PACK

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES, INC.·Product code LRO·April 28, 2014

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 10, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 22, 2010

    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