48 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
BM Test HbA1c Diluent
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Control
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Calibrator
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Reagent 1
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Reagent 2
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test Bath Fluid 60Z
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
BM Test Bath Fluid 50
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
BM Test Cuvette Conditioner
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
BM Test Acid Solution 2
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
BM Test Alkaline Solution 2
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
Cuvette Conditioner 3
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
Cuvette Wash Solution 3
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
Internal Standard
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
ISE BUFFER
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
ISE Urine Standard Set
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
ISE Serum Standard Set (NA)
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
ISE Detergent Solution
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
Reagent Probe Wash S
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market
Reagent Probe Wash K
Device
EU IVDR
·
Eu Ivd Class A
·JEOL Ltd. MF·On the market