BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    OR3O Dual Mobility Liners

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNERGY ODM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    XENFORM SOFT TISSUE REPAIR MATRIX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PAJ·November 6, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 19, 2011

    ELECTRIC PEN DRIVE 60,000 RPM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWE·July 18, 2013

    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

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025