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

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    ENDOTRACHEAL CPAP SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMR HUMERAL HEAD Ø48 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·April 9, 2024

    MICRO-AIRE 4220-000 OSCILLATING SAW

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

    ORIGINALS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 27, 2014

    PRIM SYM SET 2 CL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 9, 2013

    CPT HIP SYSTEM TAPER STEM INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·November 2, 2010

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·March 28, 2024

    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