DWGClass II
Electrosurgical Device
General, Plastic Surgery · 21 CFR 878.4400
MDR events254All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances4All time
Recent MDR events
254 adverse event reports on file
- PHASTIPP DISPOSABLE RESECTORMar 30, 2026MalfunctionLemaitre Vascular, Inc.1220948-2026-00060
- PHASTIPP DISPOSABLE RESECTORMar 6, 2026MalfunctionLemaitre Vascular, Inc.1220948-2026-00039
- THERMIVAAug 21, 2024InjurySpinesmith Holdings,llc3006404071-2024-00006
- PEDIMAG BLOOD PUMPJun 13, 2024MalfunctionThoratec Corporation2916596-2024-03509
- THERMIVAMay 15, 2024InjurySpinesmith Holdings,llc3006404071-2024-00005
- THERMIGENApr 11, 2024InjurySpinesmith Holdings,llc3006404071-2024-00004
- THERMIGENFeb 14, 2024InjurySpinesmith Holdings,llc3006404071-2024-00003
- THERMIFeb 1, 2024InjurySpinesmith Holdings,llc3006404071-2024-00001
- CERTIFIED THERMIRF+Nov 19, 2023InjurySpinesmith Holdings,llc3006404071-2023-00006
- THERMI250Nov 19, 2023InjurySpinesmith Holdings,llc3006404071-2023-00002
Event type breakdown
Malfunction209
Injury42
Unspecified2
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
510(k) clearances
4 clearances for this product code