BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    FILMARRAY GASTROINTESTINAL (GI) PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII

    Adair Breast Clamp

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896102644·Adair Breast Clamp

    LIFE SPINE INTERSPINOUS FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUICKELISA ANTHRAX-PA KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 9, 2015

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 3, 2014

    SECURE ACUTE CARE BED 3/01

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 31, 2013

    SYSTEM 5 SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 17, 2011

    BD VIPER¿ LT SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 13, 2023

    SMALL BATTERY DRIVE 12V BATTERY

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·December 8, 2015

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 14, 2015

    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019