8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
BARE Wireguided Balloon Dilation Catheter (1235)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
FDA 510(k)
FDA Class 2
·Microbiology
VERABAND
FDA 510(k)
FDA Class 2
·Neurology
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·November 11, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 11, 2011
MONOCRYL PLUS SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 30, 2013
TELEGRAPH®
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489539879·
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