BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    HYLATOPICPLUS CREAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306803499·Standard Ratchet

    Vienna Ring CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213052628·Bolt for Needle Fixation Tool, 30mm

    FLEXLINE CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·December 28, 2010

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 18, 2011

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 9, 2013

    ON-QPAINBUSTER: SILVERSOAKER5IN:400ML, 2+2ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW, LLC.·Product code MEB·September 16, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 1, 2011

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025