Mauna Kea Technologies
PARIS Ile-de-France, FR
MAUNA KEA TECHNOLOGIES appears in FDA device records in PARIS Ile-de-France, FR. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Mauna Kea Technologies between 2005 and 2022. The busiest year on record is 2012, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220477 | Cellvizio 100 series system with confocal Miniprobes | OWN | Substantially Equivalent | |
| K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K193416 | Cellvizio I.V.E. with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K191144 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | OWN | Substantially Equivalent | |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | GWG | Substantially Equivalent | |
| K172844 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K151593 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | |
| K141358 | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES | OWN | Substantially Equivalent | |
| K133466 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) | OWN | Substantially Equivalent | |
| K123676 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | |
| K122042 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | |
| K120208 | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | |
| K111047 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | |
| K061666 | CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX | GCJ | Substantially Equivalent | |
| K051585 | F-400 SYSTEM | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004542960 | 3004542960 | MAUNA KEA TECHNOLOGIES | 9, RUE D ENGHIEN, PARIS Ile-de-France F-75010 FR | 2026 | |
| 3007536946 | 3007536946 | Mauna Kea Technologies INC. | 24 Denby Road, Suite 140, Allston, MA 02134 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain