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

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    ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LASER 3 SPSC300

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CONTOUR®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012

    BREEZE2

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    PROFEMUR(R) HIP STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010

    CONTOUR

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019

    CONTOUR® TS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025

    SECURE ACUTE CARE BED 3/01

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 17, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

    INRATIO2

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

    CONTOUR® TS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025

    CONTOUR® TS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

    CONTOUR®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021