FEI 2828
Terumo Corp.
44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JP
MDR events1,414All time
Recalls0All time
Registered products29
Establishment typeExportExport Device to the United States But Perform No Other Operation on Device
Registered product codes
29 product codes
Recent MDR events
1,414 on file
- RUNTHROUGHJun 30, 2026Death25664207
- PROGREATJun 9, 2026MalfunctionMW5189151
- RADIFOCUS GLIDEWIRE ADVANTAGEMar 31, 2026InjuryMW5186170
- GLIDE ADVANTAGE .014 WIREMar 11, 2026InjuryMW5185118
- RUNTHROUGH NS PTCA GUIDE WIREMar 9, 2026DeathMW5184894
- TERUMO COIL DETACHERMar 5, 2026Malfunction24521757
- RADIFOCUS GLIDEWIREDec 18, 2025InjuryMW5180837
- 2.8FR PROGREAT MICROCATHETEROct 28, 2025MalfunctionMW5178058
- RUNTHROUGH FLOPPY WORKHORSE GUIDEWIREOct 28, 2025MalfunctionMW5178059
- CROSSTELLA RX PTA BALLOON CATHETEROct 27, 2025InjuryMW5177999
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 2828.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.