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

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    UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209118373·KIT, RE-SUPPLY - CUSTOM

    QuadraSphere Microspheres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DURA-GUARD

    FDA Adverse Event
    SYNOVIS LIFE TECHNOLOGIES, INC.·Product code GXQ·May 6, 2014

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 2, 2012

    M-1 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FPO·September 21, 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