10 results
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20ms
·
Sources: EU EUDAMED, US FDA
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
R:GEN Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
NextAR Spine Platform
FDA 510(k)
FDA Class 2
·Neurology
RECIPROC FILES 6X
FDA Adverse Event
Malfunction
·DENTSPLY VDW GMBH·Product code EKS·June 26, 2019
RECIPROC FILES 6X
FDA Adverse Event
Malfunction
·DENTSPLY VDW GMBH·Product code EKS·June 26, 2019
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
ACCU-CHEK SPIRIT COMBO
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
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
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