10 results
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18ms
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Sources: EU EUDAMED, US FDA
Velocity Alpha MR High Speed Surgical Drill System
FDA 510(k)
FDA Class 2
·Neurology
Omnipod 5 SmartBolus Calculator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Corin TriFit TS Hip
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 21, 2022
TELIGEN IS-1/DF-1 - DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS·Product code LWS·November 11, 2008
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·August 10, 2011
MONOCRYL POLIGLECAPRONE 25 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·July 30, 2013
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·August 22, 2022
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