GIEClass II
Fibrometer
Hematology · 21 CFR 864.5400
MDR events5All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
5 adverse event reports on file
- AESCULAPSep 16, 2025InjuryAesculap Ag2916714-2025-00064
- LIGASUREApr 23, 2021MalfunctionCovidien11715205
- MULTIDEBRIDER POWER CONSOLEAug 12, 2020MalfunctionGyrus Acmi, Inc1037007-2020-00033
- MULTIDEBRIDER HANDPIECE, ANGLEDJul 13, 2020MalfunctionGyrus Acmi, Inc1037007-2020-00020
- BBL FIBROMETERJul 14, 1995InjuryBecton Dickinson Microbiology24324
Event type breakdown
Malfunction3
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code