BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Intacs Procedure Marker

    FDA UDI
    ADDITION TECHNOLOGY, INC.·00850048576032·The Procedure Marker, 0.9 mm is used for markin...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756376112·EXTREMITY PACK

    DAYTONA ANTERIOR CERVICAL CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HARRIS HEMATOXYLIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 2, 2014

    AFFINITY 3 BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·December 4, 2012

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·January 31, 2008

    SCREW, FIXATION, BONE

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