Mauna Kea Technologies

FDA Filings

This page includes the latest FDA filings for Mauna Kea Technologies. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FRANCEEURONEXT PARISMKEADUNS 394136118
FDA Registration(s)
Registration Number3007536946
FEI Number3007536946
NameMauna Kea Technologies INC.
Owner & OperatorMauna Kea Technologies
Contact Address9, RUE D'ENGHIEN --
PARIS FR-NOTA F-75010 FR
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address24 Denby Road, Suite 140
Allston, MA 02134 US



Registration Number3004542960
FEI Number3004542960
NameMichael A. Daniel
Owner & OperatorMauna Kea Technologies
Contact Address9, RUE D'ENGHIEN --
PARIS FR-NOTA F-75010 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address340 Jones Lane
Gardnerville, NV 89460 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Mauna Kea Technologies
Cellvizio I.V.E. System With Confocal Miniprobes2021-08-18
MAUNA KEA TECHNOLOGIES
CystoFlex™ F N 2020-05-25
MAUNA KEA TECHNOLOGIES
UroFlex™ N 2020-05-25
MAUNA KEA TECHNOLOGIES
CelioFlex™ 5 N 2020-05-25
MAUNA KEA TECHNOLOGIES
CholangioFlex™ N 2020-05-25
MAUNA KEA TECHNOLOGIES
AQ-Flex™ 19 N 2020-05-25
MAUNA KEA TECHNOLOGIES
CystoFlex™ R N 2020-05-25
MAUNA KEA TECHNOLOGIES
ColoFlex™ N 2020-05-25
MAUNA KEA TECHNOLOGIES
GastroFlex™ N 2020-05-25
MAUNA KEA TECHNOLOGIES
AlveoFlex™ N 2020-05-25
MAUNA KEA TECHNOLOGIES
Cellvizio® I.V.E. 2020-05-25
MAUNA KEA TECHNOLOGIES
CystoFlex™UHD R MP-0013-HCYS-CK2020-05-07
MAUNA KEA TECHNOLOGIES
CystoFlex™F MP-0012-CYS-CK2020-05-07
MAUNA KEA TECHNOLOGIES
UroFlex™B MP-0011-URF-CK2020-05-07
MAUNA KEA TECHNOLOGIES
Cellvizio® 100 series (488nm) CS-100-488-CK-32020-05-07
MAUNA KEA TECHNOLOGIES
Cellvizio® 100 series (488nm) CS-100-448-CK-12020-05-07
Mauna Kea Technologies
Cellvizio I.V.E. With Confocal Miniprobes2020-02-28
Mauna Kea Technologies
Cellvizio 100 Series System With Confocal Miniprobes2020-01-24
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series with Confocal Miniprobes2019-12-04
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series with Confocal Miniprobes2019-12-04
Mauna Kea Technologies
Cellvizio 100 Series Confocal Laser Imaging Systems And Their Confocal Miniprobes2019-02-22
Michael A. Daniel [Mauna Kea Technologies]
CranioFlex?2018-08-08
Michael A. Daniel [Mauna Kea Technologies]
CranioFlex?-C2018-08-08
Michael A. Daniel [Mauna Kea Technologies]
CranioFlex?2018-08-08
Michael A. Daniel [Mauna Kea Technologies]
CranioFlex?-C2018-08-08
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series Systems with Confocal Miniprobes2018-07-06
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series Systems with Confocal Miniprobes2018-07-06
Mauna Kea Technologies
Cellvizio 100 Series Systems With Confocal Miniprobes2018-05-22
Mauna Kea Technologies
Cellvizio 100 Series System With Confocal Miniprobes2017-12-15
Michael A. Daniel [Mauna Kea Technologies]
CelioFlex UHD Confocal Miniprobes to be used with Cellvizio 100 Series Systems2017-11-10
Michael A. Daniel [Mauna Kea Technologies]
CelioFlex UHD Confocal Miniprobes to be used with Cellvizio 100 Series Systems2017-11-10
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series System with Confocal Miniprobes2017-11-10
Mauna Kea Technologies
Cellvizio 100 Series Systems With Confocal Miniprobes2017-08-04
Michael A. Daniel [Mauna Kea Technologies]
CystoFlex? UHD R-C2016-07-08
Michael A. Daniel [Mauna Kea Technologies]
CelioFlex?UHD 5-C2016-07-08
Michael A. Daniel [Mauna Kea Technologies]
CelioFlex? UHD 52016-07-08
MAUNA KEA TECHNOLOGIES
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) With Confocal Miniprobes2016-05-20
MAUNA KEA TECHNOLOGIES
Cellvizio 100 Series System With Confocal Miniprobes2015-12-22
MAUNA KEA TECHNOLOGIES
Cellvizio 100 Series System With Confocal Miniprobes2015-10-23
Michael A. Daniel [Mauna Kea Technologies]
CystoFlex UHD R2014-11-17
Michael A. Daniel [Mauna Kea Technologies]
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)2014-11-17
Michael A. Daniel [Mauna Kea Technologies]
UROFLEX B2014-11-17
Michael A. Daniel [Mauna Kea Technologies]
CYSTOFLEX F2014-11-17
MAUNA KEA TECHNOLOGIES
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES2014-09-25
MAUNA KEA TECHNOLOGIES
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)2014-07-25
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series?2013-05-02
MAUNA KEA TECHNOLOGIES
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES2013-04-18
Michael A. Daniel [Mauna Kea Technologies]
GastroFlex M Confocal Miniprobe2012-12-21
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series2012-12-21
Michael A. Daniel [Mauna Kea Technologies]
GastroFlex M Confocal Miniprobe2012-12-21
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio 100 Series2012-12-21
Michael A. Daniel [Mauna Kea Technologies]
AlveoFlex M Confocal Miniprobe2012-12-21
MAUNA KEA TECHNOLOGIES
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES2012-09-04
MAUNA KEA TECHNOLOGIES
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES2012-04-20
Michael A. Daniel [Mauna Kea Technologies]
Cellvizio? 100 Series with Confocal Miniprobes?2011-08-19
MAUNA KEA TECHNOLOGIES
CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX2006-08-24

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