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

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    PROCHEM EXT CHEMICAL INTEGRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    AMI

    FDA Adverse Event
    Other ·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·Product code MNB·April 17, 2013

    NAVISTAR THERMOCOOL

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER·Product code OAD·April 3, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK, INC.·Product code DTB·June 10, 2008

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MAF·October 16, 2006

    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