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

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    RESMED S8 PRIME CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033841·Baltic Denture System BDLoad BDLoad ↓ Sm6 PLSEu...

    3DFIS, MODEL IES-FL-101

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMMONIA ASSAY FOR THE ADVIA 1650

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 10, 2025

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 30, 2011

    BIOSENSE WEBSTER NAVISTAR/CELCIUS THERMO-COOL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code OAD·April 24, 2008

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013