BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    FILMARRAY RP PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ArgenZ HT+ 95x10

    FDA UDI
    ARGEN CORPORATION, THE·D818120267·Dental porcelain/ceramic restoration kit

    JOBST soSoft

    FDA UDI
    BSN MEDICAL, INC.·00035664008055·SOSOFT 30-40 MM HG KNEE HIGH RIB SMALL SAND 1 E...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193235·

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 5, 2019

    FLEXIMARC, MODEL CM-0.9-2-10-GG-L

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTILUX CURING LIGHTS

    FDA 510(k)
    FDA Class 2 ·Dental

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·May 3, 2011

    VERSE POLY DRIVER SHAFT NAV

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

    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