11 results
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29ms
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Sources: EU EUDAMED, US FDA
ellacor System with Micro-Coring Technology
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813053669·BITE REG FS 50ML WINTERMINT
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124610·Modular Offset Stem 17mm x 150mm x 2mm
Med-link Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
AXS Vecta 46 Intermediate Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 13, 2014
SMOOTH HIGH PROFILE GEL MAMMARY PROSTHESES
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code FTR·September 15, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2013
COMPUTER SYSTEM EPICENTER FOR BDNLA
FDA Adverse Event
Injury
·BECTON DICKINSON DE MEXICO·Product code JQP·August 24, 2021
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·August 16, 2018
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