7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYNASOUND 601
FDA 510(k)
FDA Class 2
·Physical Medicine
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Piper GO-IO Intraosseous Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2014
EDWARDS SAPIEN TRANSCATHETER HEAR VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·October 16, 2012
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NIK·May 22, 2015
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020