9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SparkTM Clear Aligner System
FDA 510(k)
FDA Class 2
·Dental
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813058497·STERILE CARBIDE BUR HP703
QUANTIA LA(A)
FDA 510(k)
FDA Class 2
·Immunology
X-Suit NIR Biliary Metallic Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
BARD
FDA Adverse Event
Injury
·DAVOL·Product code FTL·November 25, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 15, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013