Mauna Kea Technologies, Inc.

US Last updated 23 May 2026

Devices: 26
Registries: GUDIDFDA 510(k)
FDA recalls: 0

Catalogue26

ColoFlex™ UHD-C 211-0151 Ref 211-0151

Class II FDA UDI Active
CelioFlex™ UHD 5-C 211-0155 Ref 211-0155

Class II FDA UDI Active
ColoFlex™ UHD 211-0134 Ref 211-0134

Class II FDA UDI Active
UroFlex™B 211-0142 Ref 211-0142

Class II FDA UDI
CystoFlex™F 211-0146 Ref 211-0146

Class II FDA UDI Active
Cellvizio® 100 series (488nm) 210-0027 Ref 210-0027

Class II FDA UDI Active
Cellvizio® I.V.E. FP-10001 Ref FP-10001

Class II FDA UDI Active
CranioFlex™ 211-0174 Ref 211-0174

Class II FDA UDI Active
CystoFlex™UHD R 211-0147 Ref 211-0147

Class II FDA UDI Active
Cellvizio® 100 series (488nm) 210-0027 Ref 210-0027

Class II FDA UDI
Cellvizio® 100 series (785nm) 210-0031 Ref 210-0031

Class II FDA UDI Active
AlveoFlex™ 211-0024 Ref 211-0024

Class II FDA UDI Active
GastroFlex™UHD-C 211-0152 Ref 211-0152

Class II FDA UDI Active
AQ-Flex™ 19-C 211-0211 Ref 211-0211

Class II FDA UDI Active
Cellvizio® 100 series (488nm) 210-0027 Ref 210-0027

Class II FDA UDI
AQ-Flex™19 211-0128 Ref 211-0128

Class II FDA UDI Active
UroFlex™B 211-0142 Ref 211-0142

Class II FDA UDI Active
CystoFlex™ UHD R-C 211-0154 Ref 211-0154

Class II FDA UDI Active
CystoFlex™UHD R 211-0147 Ref 211-0147

Class II FDA UDI
CholangioFlex™ 211-0112 Ref 211-0112

Class II FDA UDI Active
CystoFlex™F 211-0146 Ref 211-0146

Class II FDA UDI
CelioFlex™ UHD 5 211-0149 Ref 211-0149

Class II FDA UDI Active
AveoFlex™-C 211-0153 Ref 211-0153

Class II FDA UDI Active
GastroFlex™ UHD 211-0072 Ref 211-0072

Class II FDA UDI Active
CranioFlex™-C 211-0175 Ref 211-0175

Class II FDA UDI Active
Cellvizio 100 Series System With Confocal Miniprobes Ref K111047

Class II FDA 510(k) Active

Information

Country: US

Catalogue26

ColoFlex™ UHD-C 211-0151 Ref 211-0151

CelioFlex™ UHD 5-C 211-0155 Ref 211-0155

ColoFlex™ UHD 211-0134 Ref 211-0134

UroFlex™B 211-0142 Ref 211-0142

CystoFlex™F 211-0146 Ref 211-0146

Cellvizio® 100 series (488nm) 210-0027 Ref 210-0027

Cellvizio® I.V.E. FP-10001 Ref FP-10001

CranioFlex™ 211-0174 Ref 211-0174

CystoFlex™UHD R 211-0147 Ref 211-0147

Cellvizio® 100 series (488nm) 210-0027 Ref 210-0027

Cellvizio® 100 series (785nm) 210-0031 Ref 210-0031

AlveoFlex™ 211-0024 Ref 211-0024

GastroFlex™UHD-C 211-0152 Ref 211-0152

AQ-Flex™ 19-C 211-0211 Ref 211-0211

Cellvizio® 100 series (488nm) 210-0027 Ref 210-0027

AQ-Flex™19 211-0128 Ref 211-0128

UroFlex™B 211-0142 Ref 211-0142

CystoFlex™ UHD R-C 211-0154 Ref 211-0154

CystoFlex™UHD R 211-0147 Ref 211-0147

CholangioFlex™ 211-0112 Ref 211-0112

CystoFlex™F 211-0146 Ref 211-0146

CelioFlex™ UHD 5 211-0149 Ref 211-0149

AveoFlex™-C 211-0153 Ref 211-0153

GastroFlex™ UHD 211-0072 Ref 211-0072

CranioFlex™-C 211-0175 Ref 211-0175

Cellvizio 100 Series System With Confocal Miniprobes Ref K111047

Information