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Mauna Kea Technologies

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K220477Cellvizio 100 series system with confocal MiniprobesApril 11, 2022
K212322Cellvizio I.V.E. system with Confocal MiniprobesAugust 18, 2021
K193416Cellvizio I.V.E. with Confocal MiniprobesFebruary 28, 2020
K191144Cellvizio 100 Series System with Confocal MiniprobesJanuary 24, 2020
K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesFebruary 22, 2019
K180270Cellvizio 100 Series Systems with Confocal MiniprobesMay 22, 2018
K172844Cellvizio 100 Series System with Confocal MiniprobesDecember 15, 2017
K171345Cellvizio 100 Series Systems with Confocal MiniprobesAugust 4, 2017
K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMay 20, 2016
K150831Cellvizio 100 Series System with Confocal MiniprobesDecember 22, 2015
K151593Cellvizio 100 Series System with Confocal MiniprobesOctober 23, 2015
K141358CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBESSeptember 25, 2014
K133466CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)July 25, 2014
K123676CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBESApril 18, 2013
K122042CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBESSeptember 4, 2012
K120208CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBESApril 20, 2012
K111047CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBESAugust 8, 2011
K061666CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEXAugust 24, 2006
K051585F-400 SYSTEMSeptember 6, 2005