BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    HC-1 AND HC-1 CLASSIC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oticon

    FDA UDI
    Oticon A/S·05707131259028·NERA PRO, KIT 312 DIR L H BE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450279489·

    980 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 10, 2025

    CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SAPPHIRE DETACHABLE FIBER COILS

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

    HAHN TAPERED IMPLANT Ø5.0 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 6, 2024

    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