9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single-use Video Ureterorenoscope (SVU-220US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VOLUSON S6, VOLUSON S8
FDA 510(k)
FDA Class 2
·Radiology
COMPRESSOR MINI
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code BTI·August 30, 2019
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 19, 2008
ISOLINE
FDA Adverse Event
Injury
·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·September 9, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013
NEEDLE SFTYGLD 21X1-1/2 RB TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·May 30, 2019
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014