BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACIER

    FDA UDI
    PETERS SURGICAL·03661522030929·

    ARGENCO W+ (5 dwt)

    FDA UDI
    ARGEN CORPORATION, THE·D818120246·Alloy other noble metal

    JOBST soSoft

    FDA UDI
    BSN MEDICAL, INC.·00035664007522·SOSOFT 8-15 MM HG KNEE HIGH RIB SMALL BLACK 1 E...

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·August 12, 2019

    MAX-IF1000

    FDA 510(k)
    FDA Class 2 ·Neurology

    MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

    ENDOSKELETON® TAS

    FDA Adverse Event
    Injury ·TITAN SPINE, LLC·Product code OVD·March 29, 2017

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 20, 2013

    GEMSTAR PM THERAPY S

    FDA Adverse Event
    Injury ·HOSPIRA, INC.·Product code FRN·June 7, 2011

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·August 14, 2008

    MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

    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