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

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    PATIENT AID, MODEL DM-351

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CALCIUM CHLORIDE (0.025M)

    FDA 510(k)
    FDA Class 2 ·Hematology

    FLOCHANNEL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    METRX(TM) SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·March 21, 2025

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 30, 2014

    BIOTRONIK DEFIBRILLATOR PACEMAKER LEAD

    FDA Adverse Event
    Injury ·BIOTRONIK·Product code NVZ·October 9, 2012

    ACCLAIM ENCORE 2.25

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·July 29, 2010

    Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018

    Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·March 6, 2019

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LNH·March 16, 2018

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018