Company ยท US
Graphic Controls Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1998. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRX | Electrode, Electrocardiograph | 17 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 6 |
| GYB | Media, Electroconductive | 5 |
| KXO | Monitor, Pressure, Intrauterine | 5 |
| DRS | Transducer, Blood-Pressure, Extravascular | 4 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| GXY | Electrode, Cutaneous | 2 |
| KRA | Catheter, Continuous Flush | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 |
| FOK | Pad, Neonatal Eye | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 |
| HGM | System, Monitoring, Perinatal | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
| MMK | Container, Sharps | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 1998 | K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE Graphic Controls Corp. | DRX |
| Nov 5, 1998 | K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE Graphic Controls Corp. | MKJ |
| Jul 14, 1998 | K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) Graphic Controls Corp. | KXO |
| May 12, 1998 | K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE Graphic Controls Corp. | MKJ |
| Aug 27, 1997 | K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE Graphic Controls Corp. | MKJ |
| Mar 27, 1997 | K964387 | POINT OF USE II SHARPS-A-GATOR Graphic Controls Corp. | MMK |
| Jan 22, 1997 | K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) Graphic Controls Corp. | KXO |
| Nov 19, 1996 | K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE Graphic Controls Corp. | DRX |
| Nov 15, 1996 | K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE Graphic Controls Corp. | DRX |
| Oct 28, 1996 | K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 Graphic Controls Corp. | DRX |
| Oct 24, 1996 | K955923 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL Graphic Controls Corp. | MKJ |
| Oct 24, 1996 | K955882 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS Graphic Controls Corp. | MKJ |
| Jul 25, 1996 | K955828 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS Graphic Controls Corp. | MKJ |
| Jul 9, 1996 | K955597 | MEDI-TRACE DEFIB PADS Graphic Controls Corp. | GYB |
| Jun 7, 1996 | K961395 | MEDI-TRACE RADIOLUCENT Graphic Controls Corp. | DRX |
| Jul 24, 1995 | K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER Graphic Controls Corp. | KXO |
| Jul 7, 1995 | K950485 | GRAPHIC CONTROLS PROTRACE ECG ELECTRODE Graphic Controls Corp. | DRX |
| Jul 7, 1995 | K945479 | MEDI-TRACE(R) 500 ECG ELECTRODE Graphic Controls Corp. | DRX |
| Jul 3, 1995 | K950489 | GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE Graphic Controls Corp. | DRX |
| Jul 3, 1995 | K950488 | GRAPHIC CONTROLS BIOTAC ECO ELECTRODE Graphic Controls Corp. | DRX |
| Jun 22, 1995 | K950782 | MEDI-TRAC EEG ELECTRODE Graphic Controls Corp. | GXY |
| May 25, 1995 | K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 Graphic Controls Corp. | KXO |
| May 17, 1995 | K950487 | GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE Graphic Controls Corp. | DRX |
| May 17, 1995 | K950486 | GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE Graphic Controls Corp. | DRX |
| Nov 10, 1994 | K945214 | MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE Graphic Controls Corp. | DRX |
| Oct 20, 1994 | K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE Graphic Controls Corp. | HGP |
| Oct 19, 1993 | K933365 | BABISTICK Graphic Controls Corp. | FMK |
| Mar 15, 1993 | K926118 | LIFE TRACE(R) BILIRUBIN MASK Graphic Controls Corp. | FOK |
| Jan 14, 1992 | K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER Graphic Controls Corp. | KXO |
| Jul 16, 1991 | K910418 | LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 Graphic Controls Corp. | HGM |
| Mar 29, 1991 | K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER Graphic Controls Corp. | HFM |
| Jan 29, 1991 | K905130 | FETAL MONITORING SPIRAL ELECTRODE Graphic Controls Corp. | HGP |
| Jan 29, 1991 | K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE Graphic Controls Corp. | HGP |
| Sep 27, 1990 | K903973 | GARDOSI BIRTHING CUSHION Graphic Controls Corp. | KNC |
| Sep 19, 1989 | K891193 | MEDI-TRACE ACCU-NATE DEVICE Graphic Controls Corp. | FPA |
| Apr 6, 1989 | K891192 | MEDI-TRACE THERMAL VIDEO FILM PAPER Graphic Controls Corp. | LMD |
| Feb 10, 1987 | K864722 | MEDI-TRACE INFANT ELECTRODE Graphic Controls Corp. | DRX |
| May 28, 1985 | K843580 | MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO Graphic Controls Corp. | DRS |
| Apr 1, 1984 | K834445 | MEDI-TRACE QUIKSET DX DIAG. ELECT- Graphic Controls Corp. | DRX |
| Nov 1, 1982 | K822750 | MEDI-TRACE 5' OFFSET ELECTRODE Graphic Controls Corp. | DRX |
| May 18, 1982 | K821137 | MEDITRACE PELLET ELECTRODE Graphic Controls Corp. | DRX |
| Mar 12, 1982 | K820457 | MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS Graphic Controls Corp. | DRS |
| Jun 12, 1981 | K811410 | MEDI-TRACE Graphic Controls Corp. | KRA |
| Aug 27, 1980 | K801829 | MEDI-TRACE DISP. FLUSHING DEV./MONITOR Graphic Controls Corp. | KRA |
| Aug 27, 1980 | K801828 | MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS Graphic Controls Corp. | DTL |
| Jun 30, 1980 | K801322 | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS Graphic Controls Corp. | DQO |
| Jun 30, 1980 | K801321 | PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE Graphic Controls Corp. | DQO |
| Apr 16, 1980 | K800706 | MEDI-TRACE DISPOSABLE DOMES/MONITORING Graphic Controls Corp. | DRS |
| Apr 16, 1980 | K800705 | MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO Graphic Controls Corp. | DRS |
| Jun 5, 1979 | K790818 | MEDI-TRACE EEG CREME Graphic Controls Corp. | GYB |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||