GZCClass IIIImplant
Stimulator, Neuromuscular, Implanted
Neurology · 21 CFR 882.5860
Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99
MDR events81All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
81 adverse event reports on file
- NEBULIZERApr 13, 2026MalfunctionMedline Industries, Lp1417592-2026-01001
- IMPLANTABLE NEUROSTIMULATORSep 24, 2022InjuryMedtronic Neuromodulation2182207-2022-01796
- VOCARE BLADDER SYSTEMNov 6, 2006MalfunctionFinetech Medical9617096-2006-00004
- VOCARE BLADDER SYSTEMNov 6, 2006MalfunctionFinetech Medical9617096-2006-00003
- FREEHANDSep 29, 2006MalfunctionNeurocontrol Corp.1530440-2006-00001
- VOCARE BLADDER SYSTEMMar 3, 2006MalfunctionFinetech Medical9617096-2006-00001
- VOCARE BLADDER SYSTEMOct 28, 2005DeathFinetech Medical Ltd.9617096-2005-00001
- *Jul 7, 2005MalfunctionAnsMW1036006
- MICROVASApr 19, 2005MicrovasMW4003923
- VOCARE BLADDER SYSTEMNov 4, 2004InjuryFinetech Medical Ltd.9617096-2004-00003
Event type breakdown
Injury41
Malfunction36
Unspecified2
Death1
Other1
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.
PMA approvals
1 premarket approvals for this product code