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

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    DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138025448·DENIM SHOULDER IMMOBILIZER W/SWATHE, SMALL

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·November 19, 2020

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 17, 2021

    NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    PSA4000 EEG MONITOR WITH FRONTAL PSI

    FDA 510(k)
    FDA Class 2 ·Neurology

    CHLORAPREP ONE STEP HI- LITE ORANGE

    FDA Adverse Event
    Injury ·CAREFUSION 213, LLC 0113·Product code KXF·October 18, 2021

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 20, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·June 10, 2011

    LEAD MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 14, 2008

    ENDO ILS 21MM, CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 3, 2017

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015