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

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    Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    NON-CONTACT TEAR FILM THERMOGRAGH

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RELINE-IT MODEL RELINE-IT

    FDA 510(k)
    FDA Class 2 ·Dental

    PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 6, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    ProScreen 5 Panel Dip Card, Item No. PSD-12BUP

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    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