BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    EZDENTI-I; E2; PRORA VIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799007148·

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131594·MUA ZS NP 1.0GH Str

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 3, 2024

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    6000 CMS IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 17, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011

    40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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