BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    MAIA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Persona Knee System

    FDA UDI
    Zimmer, Inc.·00889024485617·

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 27, 2022

    CELLTRACKS ANALYER II

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 2, 2023

    MEDTRONIC.KAPPA

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 8, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC.·Product code LYJ·June 23, 2011

    PLOYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code MSF·September 4, 2008

    Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023