BEUDAMED
    357 results · 28ms · Sources: EU EUDAMED, US FDA

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    Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Single Use Aspiration Needle NA-U200H

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Aspiration Needle NA-U200H

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Aspiration Needle NA-U401SX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Aspiration Needle NA-U201H

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ISE Serum Standard Set (NA)

    Device
    EU IVDR · Eu Ivd Class A ·JEOL Ltd. MF·On the market

    MYCOBACTERIAL DETECTION BY NA REAGENTS

    Device
    EU IVDD · Eu Ivd General ·Tosoh Corporation·On the market·30 countries

    SPOTCHEM D Electrolyte (Na, K, Cl)

    Device
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

    SPOTCHEM Electrolyte Control [Na, K, Cl]

    Device
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

    CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd General ·Tosoh Corporation·On the market·30 countries

    N/A

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Konan Medical, Inc.·1 device

    N/A

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Konan Medical, Inc.·3 devices

    SPOTCHEM D Electrolyte (Na, K, Cl)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    SPOTCHEM Electrolyte Control [Na, K, Cl]

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

    NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021