BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES

    FDA 510(k)
    FDA Class 2 ·Dental

    KONICA LASER IMAGER, DRYPRO MODEL 751/752

    FDA 510(k)
    FDA Class 2 ·Radiology

    NUMED TYSHAK II AND Z-MED II PTV CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    M AF811 MASK

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 8, 2024

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 17, 2013

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 19, 2008

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2011

    V60 VENTILATOR

    FDA Adverse Event
    Death ·RESPIRONICS CALIFORNIA, INC·Product code MNT·February 17, 2020

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015