MZMClass II
Fibrin Sealant Preparation Device
General Hospital · 21 CFR 880.5860
MDR events419All time
Recalls0All time
Registered firms12Currently listed
510(k) clearances0All time
Recent MDR events
419 adverse event reports on file
- VERAASEAL DUAL APPLICATORJul 27, 2026MalfunctionEthicon Inc.2210968-2026-07407
- VISTASEAL DUAL APPLICATORJul 27, 2026MalfunctionEthicon Inc.2210968-2026-07483
- VISTASEAL DUAL APPLICATORJul 13, 2026MalfunctionEthicon Inc.2210968-2026-07168
- VISTASEAL DUAL APPLICATORJun 26, 2026MalfunctionEthicon Inc.2210968-2026-06729
- VISTASEAL DUAL APPLICATORJun 22, 2026MalfunctionEthicon Inc.2210968-2026-06507
- VISTASEAL DUAL APPLICATORJun 22, 2026MalfunctionEthicon Inc.2210968-2026-06508
- VISTASEAL DUAL APPLICATORJun 4, 2026MalfunctionEthicon Inc.2210968-2026-06081
- FIBRIN SEALANT PREPARATION DEVICEJun 4, 2026MalfunctionEthicon Inc.2210968-2026-06082
- VISTASEAL DUAL APPLICATORJun 2, 2026MalfunctionEthicon Inc.2210968-2026-05997
- VISTASEAL DUAL APPLICATORMay 29, 2026MalfunctionEthicon Inc.2210968-2026-05955
Event type breakdown
Malfunction413
Death3
Unspecified1
Injury1
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
12 firms currently registered for this product code
Ethicon, Inc.
Somerville, NJ, US
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Ethicon, Inc.
Raritan, NJ, US
Tessy Plastics Shanghai Co., Ltd
SHANGHAI, CN
Isomedix Operations Inc.
Northborough, MA, US
Viant As&o Holdings, Llc
LACONIA, NH, US
Nypro Healthcare Baja Inc. (albuquerque)
Albuquerque, NM, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.