BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    Venue Sprint

    FDA 510(k)
    FDA Class 2 ·Radiology

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021084·FM3 - Alice 6

    SCINTILLATION GAMMA CAMERA

    FDA 510(k)
    FDA Class 2 ·Radiology

    AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 17, 2020

    GLUCOMETER ELITE 4 BASIC

    FDA Adverse Event
    Malfunction ·ARKRAY, INC.·Product code NBW·September 27, 2001

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 14, 2020

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 9, 2011

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013

    AXS VECTA 074 CATH 132CM - CE

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

    FDA Enforcement
    Class II ·Ongoing·Bridge to Life Ltd·July 30, 2025

    PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 13, 2020

    PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 2, 2020

    PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·December 15, 2020

    PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 9, 2021

    PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 17, 2020

    PN 32G 4MM 5B XTW EASYFLOW LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 18, 2020

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014