9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERIT HYDROPHILIC GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
M-Flex®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020128·Blue Silicone Tungsten Maloney Esophageal Dilat...
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
FDA 510(k)
FDA Class 2
·Hematology
OPTOS LIMITED PANORAMIC 200CAF
FDA 510(k)
FDA Class 2
·Ophthalmic
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·May 20, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·June 10, 2011
SYNCHRON LX20 PRO
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·August 14, 2008
SENTRANT INTRODUCER SHEATH
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DYB·November 11, 2025
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015