BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    TECHNICON SMAC II SYSTEM & ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ORTHOSLENDERIZER

    FDA 510(k)
    FDA Class 1 ·Dental

    EUSRA RF Electrode

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

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    MICROMAX MOTOR ASSY

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 11, 2013

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code NIP·August 11, 2010

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    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

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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