9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dental Glass Ceramics Blocks (HT,LT,ST)
FDA 510(k)
FDA Class 2
·Dental
TRIAL RING D.64
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489417153·
ELMED
FDA UDI
ELMED INCORPORATED·00198506057717·CONN STYLE AORTIC COMPRESSOR DESIGNED TO GAIN I...
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
FDA 510(k)
FDA Class 2
·Radiology
GLOVE PORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MATRIX2 STANDARD 360 SR COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION·Product code HCG·November 20, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 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