FRTClass II
Unit, Isolation, Surgical
General, Plastic Surgery · 21 CFR 878.5070
MDR events7All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
7 adverse event reports on file
- MOTIVA IMPLANTSDec 20, 2024InjuryMotiva Usa Llc3012883202-2024-00232
- MOTIVA IMPLANTSDec 13, 2024InjuryMotiva Usa Llc3012883202-2024-00218
- MOTIVA IMPLANTSDec 13, 2024InjuryMotiva Usa Llc3012883202-2024-00219
- MOTIVA IMPLANTSDec 12, 2024InjuryEstablishment Labs S.a3012883202-2024-00214
- MOTIVA IMPLANTSDec 12, 2024InjuryEstablishment Labs S.a3012883202-2024-00217
- MOTIVA IMPLANTSOct 31, 2024InjuryEstablishment Labs S.a.3012883202-2024-00070
- SILASTIC MAMMARY IMPLANTSep 13, 1996InjuryDow Corning Corp.1816403-1996-00056
Event type breakdown
Injury7
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.