BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KSEA FIBERSCOPE

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

    SYNTHES SCALLOPED DISTAL TIBIA PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    LIGASURE ADVANCE PISTOL GRIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·March 29, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 30, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·June 13, 2008

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    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