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.
| FRANCE | EURONEXT PARIS | MKEA | DUNS 394136118 |
| Registration Number | 3007536946 |
| FEI Number | 3007536946 |
| Name | Mauna Kea Technologies INC. |
| Owner & Operator | Mauna Kea Technologies |
| Contact Address | 9, RUE D'ENGHIEN -- PARIS FR-NOTA F-75010 FR |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 24 Denby Road, Suite 140 Allston, MA 02134 US |
| Registration Number | 3004542960 |
| FEI Number | 3004542960 |
| Name | Michael A. Daniel |
| Owner & Operator | Mauna Kea Technologies |
| Contact Address | 9, RUE D'ENGHIEN -- PARIS FR-NOTA F-75010 FR |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 340 Jones Lane Gardnerville, NV 89460 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| MAUNA KEA TECHNOLOGIES | Cellvizio® I.V.E. | 2024-03-07 |
| MAUNA KEA TECHNOLOGIES | AQ-Flex™ 19-C MP-0023-AQF | 2023-02-17 |
Mauna Kea Technologies | Cellvizio I.V.E. System With Confocal Miniprobes | 2021-08-18 |
| 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-CK | 2020-05-07 |
| MAUNA KEA TECHNOLOGIES | CystoFlex™F MP-0012-CYS-CK | 2020-05-07 |
| MAUNA KEA TECHNOLOGIES | UroFlex™B MP-0011-URF-CK | 2020-05-07 |
| MAUNA KEA TECHNOLOGIES | Cellvizio® 100 series (488nm) CS-100-488-CK-3 | 2020-05-07 |
| MAUNA KEA TECHNOLOGIES | Cellvizio® 100 series (488nm) CS-100-448-CK-1 | 2020-05-07 |
Mauna Kea Technologies | Cellvizio I.V.E. With Confocal Miniprobes | 2020-02-28 |
Mauna Kea Technologies | Cellvizio 100 Series System With Confocal Miniprobes | 2020-01-24 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series with Confocal Miniprobes | 2019-12-04 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series with Confocal Miniprobes | 2019-12-04 |
Mauna Kea Technologies | Cellvizio 100 Series Confocal Laser Imaging Systems And Their Confocal Miniprobes | 2019-02-22 |
Michael A. Daniel [Mauna Kea Technologies] | CranioFlex? | 2018-08-08 |
Michael A. Daniel [Mauna Kea Technologies] | CranioFlex?-C | 2018-08-08 |
Michael A. Daniel [Mauna Kea Technologies] | CranioFlex? | 2018-08-08 |
Michael A. Daniel [Mauna Kea Technologies] | CranioFlex?-C | 2018-08-08 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series Systems with Confocal Miniprobes | 2018-07-06 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series Systems with Confocal Miniprobes | 2018-07-06 |
Mauna Kea Technologies | Cellvizio 100 Series Systems With Confocal Miniprobes | 2018-05-22 |
Mauna Kea Technologies | Cellvizio 100 Series System With Confocal Miniprobes | 2017-12-15 |
Michael A. Daniel [Mauna Kea Technologies] | CelioFlex UHD Confocal Miniprobes to be used with Cellvizio 100 Series Systems | 2017-11-10 |
Michael A. Daniel [Mauna Kea Technologies] | CelioFlex UHD Confocal Miniprobes to be used with Cellvizio 100 Series Systems | 2017-11-10 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series System with Confocal Miniprobes | 2017-11-10 |
Mauna Kea Technologies | Cellvizio 100 Series Systems With Confocal Miniprobes | 2017-08-04 |
Michael A. Daniel [Mauna Kea Technologies] | CystoFlex? UHD R-C | 2016-07-08 |
Michael A. Daniel [Mauna Kea Technologies] | CelioFlex?UHD 5-C | 2016-07-08 |
Michael A. Daniel [Mauna Kea Technologies] | CelioFlex? UHD 5 | 2016-07-08 |
MAUNA KEA TECHNOLOGIES | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) With Confocal Miniprobes | 2016-05-20 |
MAUNA KEA TECHNOLOGIES | Cellvizio 100 Series System With Confocal Miniprobes | 2015-12-22 |
MAUNA KEA TECHNOLOGIES | Cellvizio 100 Series System With Confocal Miniprobes | 2015-10-23 |
Michael A. Daniel [Mauna Kea Technologies] | CystoFlex UHD R | 2014-11-17 |
Michael A. Daniel [Mauna Kea Technologies] | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) | 2014-11-17 |
Michael A. Daniel [Mauna Kea Technologies] | UROFLEX B | 2014-11-17 |
Michael A. Daniel [Mauna Kea Technologies] | CYSTOFLEX F | 2014-11-17 |
MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES | 2014-09-25 |
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 MINIPROBES | 2013-04-18 |
Michael A. Daniel [Mauna Kea Technologies] | GastroFlex M Confocal Miniprobe | 2012-12-21 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series | 2012-12-21 |
Michael A. Daniel [Mauna Kea Technologies] | GastroFlex M Confocal Miniprobe | 2012-12-21 |
Michael A. Daniel [Mauna Kea Technologies] | Cellvizio 100 Series | 2012-12-21 |
Michael A. Daniel [Mauna Kea Technologies] | AlveoFlex M Confocal Miniprobe | 2012-12-21 |
MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | 2012-09-04 |
MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES | 2012-04-20 |
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 GASTROFLEX | 2006-08-24 |
MAUNA KEA TECHNOLOGIES | F-400 SYSTEM | 2005-09-06 |
| NCAGE Code | FAUD6 | MAUNA KEA TECHNOLOGIES |
| CAGE Code | FAUD6 | MAUNA KEA TECHNOLOGIES |