22 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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Immudex ApS
Manufacturer
🇩🇰 Denmark
ITC HEARING AID CLUB MODEL LM50H
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ITC HEARING AID CLUB MODEL LM40
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BTE HEARING AID CLUB MODEL ST70
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BTE HEARING AID CLUB MODEL: ST60
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Vibe SF Self-Fitting Hearing Aid
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ITC HEARING AID CLUB MODEL LM50
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WSA Self-Fitting Hearing Aid Gen 2
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Free-standing toilet aid Model FRIGG, 300 Kg
Device
EU MDR
·
Eu Md Class 1
·HMN A/S·On the market·1 country
Free-standing toilet aid Model FRIGG 52 cm
Device
EU MDR
·
Eu Md Class 1
·HMN A/S·On the market
Free-standing toilet aid model FRIGG 44 cm
Device
EU MDR
·
Eu Md Class 1
·HMN A/S·On the market
Free standing toilet aid Model FRIGG 61 cm, 200kg
Device
EU MDR
·
Eu Md Class 1
·HMN A/S·On the market
Free-standing toilet aid Model FRIGG, 400 Kg (85 cm)
Device
EU MDR
·
Eu Md Class 1
·HMN A/S·On the market·32 countries
BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)
Device
EU MDR
·
Eu Md Class 2a
·WSAUD A/S·On the market·32 countries
BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)
Device
EU MDR
·
Eu Md Class 2a
·WSAUD A/S·On the market·32 countries
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
FDA Enforcement
Class II
·Terminated·Widex A/S·October 17, 2018
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Enforcement
Class II
·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Enforcement
Class II
·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Enforcement
Class II
·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW
FDA Enforcement
Class II
·Terminated·GN Hearing A/S·December 4, 2019