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

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    ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE

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

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ELECSYS FSH II CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT CORP.·Product code CBK·March 18, 2011

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·June 17, 2008

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Enforcement
    Class II ·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024

    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