GZDClass IIIImplant
Stimulator, Spinal-cord, Implanted, For Bladder Evacuation
Neurology · 21 CFR 882.5850
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
MDR events5All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
5 adverse event reports on file
- PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAYMar 15, 2007OtherB. Braun Medical2523676-2007-00012
- LONE START MEDICAL PRODUCTS INCNov 28, 2006MalfunctionLone Star Medical ProductsMW1041173
- EPIDURAL CATHETERJan 19, 1995InjuryConcord/portex25748
- PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAYJul 28, 1994InjuryB. Braun Medical, Inc.21132
- SPINAL EPIDURAL STIMULATORFeb 4, 1994MalfunctionMedtronics7757
Event type breakdown
Injury2
Malfunction2
Other1
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.