6,443 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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RR-10(W/O DCL)
Device
EU IVDR
·
Eu Ivd Class A
·SYSMEX CORPORATION·On the market·32 countries
Transport Belt 4 (w/o ISE)
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
Transport Belt 3 (w/o ISE)
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
Transport Belt 2 (w/o ISE)
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
Transport Belt 1 (w/o ISE)
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS
Device
EU MDR
·
Eu Md Class 2a
·TSK Laboratory International Japan KK·On the market·1 country
PENTAX Balloon/O-ring kit OF-A67
Device
EU MDD
·
Eu Md Class 1
·HOYA Corporation ·On the market·32 countries
NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
Transport Belt 4 (w/o ISE)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·1 device
Transport Belt 3 (w/o ISE)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·1 device
Transport Belt 2 (w/o ISE)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·1 device
Transport Belt 1 (w/o ISE)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·1 device
PENTAX Balloon/O-ring kit OF-A67
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·HOYA Corporation ·1 device
ASAHI Veloute/ASAHI Tellus
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·1 device
ASAHI ZenyteEX PTCA GUIDING CATHETER
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·ASAHI INTECC CO., LTD.·1 device
ASAHI ZenyteEX PTCA GUIDING CATHETER
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·ASAHI INTECC CO., LTD.·1 device
Determine HIV Early Detect
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
TOP Endoscopic Hood
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·TOP Corporation·1 device
TOP Lesion Generator
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·TOP Corporation·1 device
UF- Fluorocell SF
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·SYSMEX CORPORATION·1 device