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

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    Filters Regulation: Us FDA ×

    Infrared Ear Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUICKVUE INFLUENZA A + B TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ISOGRAY TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·September 27, 2017

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 7, 2011

    POLYFLUX LR CAPILLARY DIALYZER

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

    dS Breast 16ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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