BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 13, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 13, 2024

    BALLERT CRANIAL MOLDING HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEPUY STTUNE (TM) PS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·January 11, 2013

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·November 17, 2010

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITI·July 3, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015