BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    HDL PRECIPITANT REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·May 14, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Injury ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 20, 2012

    PATIENT ROOM WALL SAVER RECL

    FDA Adverse Event
    Malfunction ·STRYKER CORP MEDICAL DIV·Product code FRK·September 10, 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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018