BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    7MM CUTTING REAMER

    FDA UDI
    Biomet Orthopedics, LLC·00880304461345·

    Cutting Reamer

    FDA UDI
    Biomet Orthopedics, LLC·00887868556678·

    PUR UCLA Abutment RP Non-Engaging - GOLD

    FDA UDI
    STERNGOLD DENTAL LLC·00841549113499·PUR UCLA Abutment RP Non-Engaging Gold. The UC...

    B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE

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

    MODIFIED IVT PERIPHERAL ATHERECTOMY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE-NORTH AMERICA·Product code KDI·May 16, 2008

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 1, 2014

    SPACEMAKER EXTRA VIEW BALLOON - ROUND

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·December 4, 2012

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    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