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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Titanium TomoFix Medial High Tibia Plate Anatomical

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mouse anti-Cytokeratin 8 &18 (UCD/PR-10.11) Concentrate

    FDA UDI
    LIFE TECHNOLOGIES CORPORATION·10190302007955·

    BALANCE MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304446434·

    VIDAS® TOXO IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LGD·June 9, 2017

    VIDAS® TOXO IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LGD·June 15, 2017

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034197·Profile Zero Shunt Plate, Groove

    VIDAS® TOXO IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, S.A.·Product code LGD·June 13, 2017

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694065863·Profile 0 Bur Hole Groove Shunt Plate Sterile Q...

    GE DATEX-OHMEDA AISYS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LUMANOSITY CELEBRITY, MODEL 204

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 9, 2021

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·January 22, 2020

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 20, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 27, 2011

    CIRCULAR STAPLER, 29MM DIGITAL LOADING UNIT

    FDA Adverse Event
    Injury ·POWER MEDICAL INTERVENTIONS·Product code GDW·September 29, 2008

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 8, 2018

    NOVA MAX PLUS GLUCOSE MONITOR

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL CORPORATION·Product code NBW·February 13, 2015

    BD NEEDLE 27GA 1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·June 3, 2019

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·March 10, 2020