FEI 3002807795
Olympus Medical Systems Corp.
2951 ISHIKAWA-CHO, HACHIOJI-SHI Tokyo, JP
MDR events52,511All time
Recalls0All time
Registered products74
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
74 product codes
Recent MDR events
52,511 on file
- SINGLE USE BIOPSY VALVE (Sterile)Jul 29, 2026Injury3003637092-2026-00154
- SINGLE USE DISTAL COVERJul 28, 2026Malfunction3003637092-2026-00153
- VIZISHOT SINGLE USE ASPIRATION NEEDLEJul 21, 2026Malfunction25891134
- SINGLE USE BIOPSY VALVE (STERILE)Jul 21, 2026Injury3003637092-2026-00152
- SINGLE USE DISTAL COVERJul 20, 2026Malfunction3003637092-2026-00151
- SINGLE USE DISTAL COVERJul 10, 2026Malfunction3003637092-2026-00150
- SINGLE USE DISTAL COVERJul 10, 2026Malfunction3003637092-2026-00149
- THUNDERBEAT OPEN FINE JAW TYPE XJul 9, 2026Malfunction25761647
- SINGLE USE DISTAL COVERJul 9, 2026Malfunction3003637092-2026-00148
- SINGLE USE PRELOADED SPHINCTEROTOME VJul 9, 2026MalfunctionMW5190561
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002807795.
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
8 on file
Top refusal reasons
Compare to industry ↗- Division of West Coast Imports (DWCI)Nov 2, 2023
77EOQ \ BRONCHOSCOPE (FLEXIBLE OR RIGID)
- Division of West Coast Imports (DWCI)Nov 2, 2023
78FDF \ COLONOSCOPE, GASTRO-UROLOGY
- Division of West Coast Imports (DWCI)Nov 2, 2023
78FDF \ COLONOSCOPE, GASTRO-UROLOGY
- Division of West Coast Imports (DWCI)Nov 2, 2023
78FDS \ GASTROSCOPE, GASTRO-UROLOGY
- Division of West Coast Imports (DWCI)Nov 2, 2023
78FDS \ GASTROSCOPE, GASTRO-UROLOGY
- Division of West Coast Imports (DWCI)Nov 2, 2023
78FAJ \ CYSTOSCOPE, DIAGNOSTIC
- Division of West Coast Imports (DWCI)Nov 2, 2023
78GDB \ ENDOSCOPE, FIBER OPTIC
- Division of West Coast Imports (DWCI)Nov 2, 2023
78PPE \ NEPHROSCOPE SET