BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    CAD 12, COLONOSCOPY ASSIST DEVICE

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

    Bosworth Pit & Fissure

    FDA UDI
    Harry J Bosworth Company·H6680921561·Pit & Fissure LC Sealant w Fluoride

    APPRAISE URINE MICROALBUMIN COLLECTION KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMAGINE H.E.

    FDA 510(k)
    FDA Class 2 ·Dental

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2020

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 26, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·May 3, 2013

    UNKNOWN - UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·August 21, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 27, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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