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

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    STOVALL ENDOMETRIAL BRUSH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK116201·DD tempMED are pre-colored dental milling blank...

    4911620

    FDA Adverse Event
    Malfunction ·June 26, 2015

    SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQY·June 27, 2014

    SIGMA PS CEM FEM SZ4 L

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·November 29, 2010

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·January 3, 2007

    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