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

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    EMMA Capnograph

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EarQ

    FDA UDI
    Oticon A/S·05707131353740·G40 S, MINIRITE T 312 2.4G C063 EARQ

    JMS A.V. FISTULA NEEDLE SET

    FDA UDI
    JMS SINGAPORE PTE LTD·08888483005086·A.V.FISTULA 15GX11/4" BE 30CM W/CLAMP

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·August 5, 2020

    DND 101

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DIGITAL FLAT PANEL X-RAY DETECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2015

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2015

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 20, 2017

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·June 26, 2013

    SIGMA 300 D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025