MAUNA KEA TECHNOLOGIES
17 clearances · 6 inspections · aggregated across 3 source records
Scorecard
Events per device across the 35-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
35 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| ColoFlex™ UHD | 211-0134 | OWN | 03760187910055 | 2 |
| GastroFlex™ UHD | 211-0072 | OWN | 03760187910079 | 2 |
| AQ-Flex™ 19-C | 211-0211 | OWN | 03760187910772 | 1 |
| AlveoFlex™ | 211-0024 | OWN | 03760187910024 | 1 |
| AveoFlex™-C | 211-0153 | OWN | 03760187910192 | 1 |
| CelioFlex™ UHD 5 | 211-0149 | OWN | 03760187910260 | 1 |
| CelioFlex™ UHD 5-C | 211-0155 | OWN | 03760187910277 | 1 |
| Cellvizio® 100 series (488nm) | 210-0027 | OWN | 03760187911007 | 1 |
| Cellvizio® 100 series (488nm) | 210-0027 | OWN | 00827002472693 | 1 |
| Cellvizio® 100 series (488nm) | 210-0027 | OWN | 00827002472716 | 1 |
| Cellvizio® 100 series (785nm) | 210-0031 | OWN | 03760187911014 | 1 |
| CholangioFlex™ | 211-0112 | OWN | 03760187910031 | 1 |
| CranioFlex™ | 211-0174 | GWG OWN | 03760187910758 | 1 |
| CranioFlex™-C | 211-0175 | GWG OWN | 03760187910765 | 1 |
| CystoFlex™ UHD R-C | 211-0154 | OWN | 03760187910253 | 1 |
| CystoFlex™F | 211-0146 | OWN | 00827002472747 | 1 |
| CystoFlex™F | 211-0146 | OWN | 03760187910123 | 1 |
| CystoFlex™UHD R | 211-0147 | OWN | 00827002472754 | 1 |
| CystoFlex™UHD R | 211-0147 | OWN | 03760187910147 | 1 |
| GastroFlex™UHD-C | 211-0152 | OWN | 03760187910246 | 1 |
| UroFlex™B | 211-0142 | OWN | 00827002472730 | 1 |
| UroFlex™B | 211-0142 | OWN | 03760187910130 | 1 |
| AQ-Flex™ 19 N | FP-10033 | OWN | 03760187912059 | 0 |
| AQ-Flex™19 | 211-0128 | OWN | 03760187910109 | 0 |
| AlveoFlex™ N | FP-10029 | OWN | 03760187912011 | 0 |
| CelioFlex™ 5 N | FP-10036 | OWN | 03760187912080 | 0 |
| Cellvizio® I.V.E. | FP-10001 | OWN | 03760187912004 | 0 |
| Cellvizio® I.V.E. | FP-10001 | OWN | 03760187913001 | 0 |
| CholangioFlex™ N | FP-10035 | OWN | 03760187912073 | 0 |
| ColoFlex™ N | FP-10031 | OWN | 03760187912035 | 0 |
Showing 1–30 of 35Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3004542960 | MAUNA KEA TECHNOLOGIES | PARIS Ile-de-France, FR | NAI |