8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASK ARTIFICIAL RESPIRATION
FDA 510(k)
FDA Class 1
·Anesthesiology
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CAAS MRV VERSION 3.0
FDA 510(k)
FDA Class 2
·Radiology
THRUWAY GUIDE WIRES
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·March 7, 2011
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 21, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2012
7 MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOSVASCULAR, LLC·Product code GCJ·July 14, 2010
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025