BWAClass II
Unit, Electrosurgical And Coagulation, With Accessories
General, Plastic Surgery · 21 CFR 878.4400
MDR events98All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances3All time
Recent MDR events
98 adverse event reports on file
- VALLEYLABMay 27, 2026MalfunctionCovidien3026612481-2026-00027
- VALLEYLABMar 26, 2026InjuryCovidien3026612481-2026-00019
- VALLEYLABJan 16, 2026MalfunctionCovidien3026612481-2026-00002
- VALLEYLABNov 10, 2025MalfunctionCovidien3026612481-2025-00022
- VALLEYLABAug 14, 2025InjuryCovidien3026612481-2025-00002
- VALLEYLABJul 3, 2025MalfunctionCovidien1717344-2025-00874
- VALLEYLABApr 14, 2025MalfunctionCovidien Mfg Dc Boulder1717344-2025-00543
- VALLEYLABJan 29, 2025MalfunctionCovidien Mfg Dc Boulder1717344-2025-00197
- VALLEYLABJan 6, 2025MalfunctionCovidien Mfg Dc Boulder1717344-2025-00020
- COVIDIEN VALLEY LAB FT 10 VLF10GEN MONOPOLAR CORD ELECTROSURGERY UNNov 7, 2024MalfunctionMedtronic Engineering And Innovation Center (meic)MW5162261
Event type breakdown
Malfunction78
Injury19
Unspecified1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
Covidien
Lafayette, CO, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Covidien
North Haven, CT, US
Steris Corporation
Saint Louis, MO, US
Elmed, Inc.
Glendale Heights, IL, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Aspen Surgical Products, Inc.
Caledonia, MI, US
Linemaster Switch Corp.
WOODSTOCK, CT, US