8 results
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20ms
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Sources: EU EUDAMED, US FDA
eXaSkin Plus
FDA 510(k)
FDA Class 2
·Radiology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813054307·PVS IMP MAT MONO 50ML RS UNFL
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
FDA 510(k)
FDA Class 2
·Cardiovascular
Pacel Bipolar Pacing Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
IACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·December 4, 2008
GYNECARE X-TRACT MOTOR DRIVE UNIT
FDA Adverse Event
Injury
·ETHICON INC.·Product code HET·July 29, 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