8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS
FDA 510(k)
FDA Class 1
·Dental
Archon
FDA UDI
Nuvasive, Inc.·00887517251824·Archon Plate, 91mm 4-Level Wide
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
FDA 510(k)
FDA Unclassified
·Unknown
Applanation tonometer AT-2
FDA 510(k)
FDA Class 2
·Ophthalmic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
HOVEROUND CORPORATION
FDA Adverse Event
Injury
·HOVEROUND CORPORATION·Product code ITI·October 20, 2010
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·December 20, 2012
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