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

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    AQUILION PREMIUM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FUSION 7D

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 12, 2012

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

    M2A MAGNUM MODULAR HEAD 46MM O.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 15, 2008

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 14, 2013

    SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 28, 2012

    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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023