BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    GYMFORM ABS-A-ROUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925011687·"C" CLAMP FOR SPECULUM HOLDER

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450188057·

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 27, 2025

    DORMA 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

    Widex

    FDA UDI
    Widex A/S·05706069575675·Widex UNIQUE U-FM (Midnight black ) 330, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069553697·Widex UNIQUE U-FA (Midnight black ) 330, Teleco...

    Widex

    FDA UDI
    Widex A/S·05706069564167·Widex UNIQUE U-FP (Midnight black ) 330, Teleco...

    Widex

    FDA UDI
    Widex A/S·05706069556384·Widex D-FA P (Midnight black ) Dream 330, Telec...

    UNKNOWN STRATA VALVE/SHUNT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·May 21, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 18, 2014

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 4, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015