10 results
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19ms
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Sources: EU EUDAMED, US FDA
MiniMed Flex pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PIEZOSURGERY PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
EXA
FDA 510(k)
FDA Class 2
·Radiology
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 6, 2024
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 2, 2023
VITALITY 2 DR
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
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 30, 2013
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 29, 2023
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