Company ยท FR
Mauna Kea Technologies
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2022. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2022 | K220477 | Cellvizio 100 series system with confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Aug 18, 2021 | K212322 | Cellvizio I.V.E. system with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Feb 28, 2020 | K193416 | Cellvizio I.V.E. with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Jan 24, 2020 | K191144 | Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Feb 22, 2019 | K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| May 22, 2018 | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies, FR | GWG |
| Dec 15, 2017 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Aug 4, 2017 | K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| May 20, 2016 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Dec 22, 2015 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Oct 23, 2015 | K151593 | Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies, FR | OWN |
| Sep 25, 2014 | K141358 | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES Mauna Kea Technologies | OWN |
| Jul 25, 2014 | K133466 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) Mauna Kea Technologies | OWN |
| Apr 18, 2013 | K123676 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES Mauna Kea Technologies | OWN |
| Sep 4, 2012 | K122042 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES Mauna Kea Technologies | OWN |
| Apr 20, 2012 | K120208 | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES Mauna Kea Technologies | OWN |
| Aug 8, 2011 | K111047 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES Mauna Kea Technologies, Inc. | OWN |
| Aug 24, 2006 | K061666 | CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX Mauna Kea Technologies, FR | GCJ |
| Sep 6, 2005 | K051585 | F-400 SYSTEM Mauna Kea Technologies, FR | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||