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

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    FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROPAQ, MODELS 402, 404

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    BENEVIEW MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIO·May 17, 2011

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·June 8, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012