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

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    Spirotrac

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EarQ

    FDA UDI
    Oticon A/S·05707131352415·G50 S, MINIRITE 312 2.4G C063 EARQ

    Lockheed - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal

    NEURO SCAN MEDICAL SYSTEMS A4000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    syngo Ultrasound Apps Suite (sUSAS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·May 19, 2016

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·May 19, 2016

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·October 16, 2008

    HUDSON SMALL VOLUME NEBULIZER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·August 3, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·March 8, 2018

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 4, 2015

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 4, 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

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021