8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MP TEST
FDA 510(k)
FDA Class 1
·Microbiology
Archon
FDA UDI
Nuvasive, Inc.·00887517253187·Archon Plate, 96mm Wide 5-Level
ULTRAEXTEND USWS-900A
FDA 510(k)
FDA Class 2
·Radiology
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 19, 2014
TRIGEN
FDA Adverse Event
Injury
·SMITH-NEPHEW INC.·Product code JDS·October 26, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 20, 2012
Hand Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015