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

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    AEROPILOT

    FDA 510(k)
    FDA Class 2 ·Radiology

    A SCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLD CORE PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

    GORE VIABAHN ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W.L. GORE & ASSOCIATES·Product code NIP·June 8, 2011

    PEN NEEDLE 32GX4MM 7 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·July 2, 2024

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Injury ·CONMED UTICA·Product code GEI·May 18, 2023

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014