Graphic Controls Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
55
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K981964MEDI-TRACE 4103 NEONATAL ELECTRODENovember 13, 1998
K983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODENovember 5, 1998
K974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)July 14, 1998
K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEMay 12, 1998
K972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEAugust 27, 1997
K964387POINT OF USE II SHARPS-A-GATORMarch 27, 1997
K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)January 22, 1997
K963151MEDI-TRACE 5700 RESTING ECG ELECTRODENovember 19, 1996
K963038MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODENovember 15, 1996
K960968MEDI-TRACE 200, MEDI-TRACE 200-30October 28, 1996
K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSOctober 24, 1996
K955923MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDALOctober 24, 1996
K955828MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORSJuly 25, 1996
K955597MEDI-TRACE DEFIB PADSJuly 9, 1996
K961395MEDI-TRACE RADIOLUCENTJune 7, 1996
K950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERJuly 24, 1995
K945479MEDI-TRACE(R) 500 ECG ELECTRODEJuly 7, 1995
K950485GRAPHIC CONTROLS PROTRACE ECG ELECTRODEJuly 7, 1995
K950489GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODEJuly 3, 1995
K950488GRAPHIC CONTROLS BIOTAC ECO ELECTRODEJuly 3, 1995