Mauna Kea Technologies - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
FDA 510(k) cleared devices by Mauna Kea Technologies General & Plastic Surgery ✕
17 devices
Cleared
Apr 11, 2022
Cellvizio 100 series system with confocal Miniprobes
General & Plastic Surgery
52d
Cleared
Aug 18, 2021
Cellvizio I.V.E. system with Confocal Miniprobes
General & Plastic Surgery
23d
Cleared
Feb 28, 2020
Cellvizio I.V.E. with Confocal Miniprobes
General & Plastic Surgery
81d
Cleared
Jan 24, 2020
Cellvizio 100 Series System with Confocal Miniprobes
General & Plastic Surgery
269d
Cleared
Feb 22, 2019
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal...
General & Plastic Surgery
58d
Cleared
Dec 15, 2017
Cellvizio 100 Series System with Confocal Miniprobes
General & Plastic Surgery
87d
Cleared
Aug 04, 2017
Cellvizio 100 Series Systems with Confocal Miniprobes
General & Plastic Surgery
88d
Cleared
May 20, 2016
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with...
General & Plastic Surgery
94d
Cleared
Dec 22, 2015
Cellvizio 100 Series System with Confocal Miniprobes
General & Plastic Surgery
267d
Cleared
Oct 23, 2015
Cellvizio 100 Series System with Confocal Miniprobes
General & Plastic Surgery
133d
Cleared
Sep 25, 2014
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
General & Plastic Surgery
125d
Cleared
Jul 25, 2014
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
General & Plastic Surgery
255d
Cleared
Apr 18, 2013
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
General & Plastic Surgery
139d
Cleared
Sep 04, 2012
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
General & Plastic Surgery
54d
Cleared
Apr 20, 2012
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
General & Plastic Surgery
87d
Cleared
Aug 24, 2006
CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600
General & Plastic Surgery
71d
Cleared
Sep 06, 2005
F-400 SYSTEM
General & Plastic Surgery
83d