FCQClass II
Light Source, Incandescent, Diagnostic
Gastroenterology, Urology · 21 CFR 876.1500
MDR events36All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
36 adverse event reports on file
- HALOGEN LIGHT SOURCEJul 30, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26207
- HALOGEN LIGHT SOURCEJul 28, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-25694
- HALOGEN LIGHT SOURCEJul 28, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-25929
- HALOGEN LIGHT SOURCEJul 8, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-23177
- HALOGEN LIGHT SOURCEJun 22, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-21331
- HALOGEN LIGHT SOURCEJun 6, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-19549
- HALOGEN LIGHT SOURCEMay 28, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-18355
- HALOGEN LIGHT SOURCEMay 25, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-17918
- HALOGEN LIGHT SOURCEMay 15, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-16242
- HALOGEN LIGHT SOURCEMay 14, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-16071
Event type breakdown
Malfunction35
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code