BEUDAMED
    16 results · 36ms · Sources: EU EUDAMED, US FDA

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    3M Comply Hydrogen Peroxide Chemical Indicator 1248

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTEGRAL X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304182554·

    INTEGRAL X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304182264·

    TWILIGHT FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 5, 2021

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·December 15, 2020

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·October 14, 2014

    HEAT START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 2019

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Enforcement
    Class II ·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020

    VIDAS® LYME IGM II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·March 3, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024