FZDClass IIImplant
Prosthesis, Ear, Internal
General, Plastic Surgery · 21 CFR 878.3590
MDR events11All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
11 adverse event reports on file
- OMNIPORE SURGICAL IMPLANTFeb 1, 2023InjuryMatrix Surgical Usa3009383407-2022-00002
- OMNIPORE SURGICAL IMPLANTDec 7, 2021InjuryMatrix Surgical Usa3009383407-2021-00004
- OMNIPORE SURGICAL IMPLANTSep 1, 2021InjuryMatrix Surgical Usa3009383407-2021-00002
- OMNIPORE SURGICAL IMPLANTSep 1, 2021InjuryMatrix Surgical Usa3009383407-2021-00003
- PROSTHESISDec 29, 2020InjuryMedtronic Xomed Inc.1045254-2020-00657
- HYDROXYLAPATITE AND FLEX H/A/Nov 17, 2015MalfunctionMedtronic XomedMW5057969
- CAUSSE LARGE LOOP PISTONDec 5, 2008OtherMedtronic Xomed, Inc.1045254-2008-00041
- CAUSSE LARGE LOOP PISTONDec 5, 2008OtherMedtronic Xomed, Inc.1045254-2008-00040
- SOUND TEC IMPLANTJan 3, 2005InjurySound Tec Inc.563247
- SOUNDTEC IMPLANTJan 3, 2005InjurySoundtec Inc563248
Event type breakdown
Injury7
Malfunction2
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code