9 results
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36ms
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Sources: EU EUDAMED, US FDA
Taurus Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Interson USB Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ENT EM
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 12, 2017
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·August 10, 2011
SENSORMEDICS 3100A
FDA Adverse Event
Malfunction
·CAREFUSION INC.·Product code LSZ·July 19, 2013
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