8 results
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19ms
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Sources: EU EUDAMED, US FDA
Sofsilk Coated Braided Silk Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VASOSTASIS VASCULAR CLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MYLABSIX ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·November 20, 2008
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2013
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
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