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

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    TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 21, 2019

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·November 21, 2019

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 24, 2020

    KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PFM-90 CEILING TUBE SUPPORT

    FDA 510(k)
    FDA Class 1 ·Radiology

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 28, 2020

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 10, 2015

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    DRIVER SOLERA 5.5/6.0 MAS CAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 1, 2014

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015