Graphic Controls Corp.
Medical device manufacturer in Buffalo, NY.
55510(k) clearances
0PMA approvals
0recalls
Device types
- DRX Electrode, Electrocardiograph 17
- MKJ Automated External Defibrillators… 6
- GYB Media, Electroconductive 5
- KXO Monitor, Pressure, Intrauterine 5
- DRS Transducer, Blood-Pressure, Extravascular 4
- HGP Electrode, Circular (Spiral), Scalp And… 3
- GXY Electrode, Cutaneous 2
- DQO Catheter, Intravascular, Diagnostic 2
- KRA Catheter, Continuous Flush 2
- MMK Container, Sharps 1
- FMK Single Use Only Blood Lancet With An… 1
- FOK Pad, Neonatal Eye 1
- HGM System, Monitoring, Perinatal 1
- HFM Monitor, Uterine Contraction, External (For… 1
- KNC Table, Obstetric (And Accessories) 1
- FPA Set, Administration, Intravascular 1
- LMD System, Digital Image Communications… 1
- DTL Adaptor, Stopcock, Manifold, Fitting… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981964 | Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional | 11/13/1998SE |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 11/05/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | 07/14/1998SE |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional | 05/12/1998SE |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 08/27/1997SE |
| K964387 | Point of Use II Sharps-A-GatorMMK · Traditional | 03/27/1997SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | 11/15/1996SE |
| K960968 | Medi-Trace 200, Medi-Trace 200-30DRX · Traditional | 10/28/1996SE |
| K955923 | Medi-Trace Combination Defibrillation & ECG Electrode for LaerdalMKJ · Traditional | 10/24/1996SE |
| K955882 | Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard DefibrillatorsMKJ · Traditional | 10/24/1996SE |
| K955828 | Medi-Trace Combination Defibrillation & ECG Electrode for Physio Control DefibrillatorsMKJ · Traditional | 07/25/1996SE |
| K955597 | Medi-Trace Defib PadsGYB · Traditional | 07/09/1996SE |
| K961395 | Medi-Trace RadiolucentDRX · Traditional | 06/07/1996SE |
| K950498 | Life Trace Trans Tip Intrauterine Pressure CatheterKXO · Traditional | 07/24/1995SE |
| K950485 | Graphic Controls Protrace ECG ElectrodeDRX · Traditional | 07/07/1995SE |
| K945479 | Medi-Trace(R) 500 ECG ElectrodeDRX · Traditional | 07/07/1995SE |
| K950489 | Graphic Controls Biotac Jr. ECG ElectrodeDRX · Traditional | 07/03/1995SE |
| K950488 | Graphic Controls Biotac Eco ElectrodeDRX · Traditional | 07/03/1995SE |
| K950782 | Medi-Trac EEG ElectrodeGXY · Traditional | 06/22/1995SE |
| K950708 | Lifetrace Intrauterine Pressure Catheter Iup 3000KXO · Traditional | 05/25/1995SE |
| K950487 | Graphic Controls Q-Trace Gold ECG ElectrodeDRX · Traditional | 05/17/1995SE |
| K950486 | Graphic Controls Q-Trace ECG ElectrodeDRX · Traditional | 05/17/1995SE |
| K945214 | Medi-Trace Neonatal ECG Electrode with Preattached LeadwireDRX · Traditional | 11/10/1994SE |
| K943732 | Life Trace Fetal Spiral Electrode with Maternal ReferenceHGP · Traditional | 10/20/1994SE |
| K933365 | BabistickFMK · Traditional | 10/19/1993SE |
| K926118 | Life Trace(R) Bilirubin MaskFOK · Traditional | 03/15/1993SE |
| K910742 | Medi-Trace Disposable Intrauterine CatheterKXO · Traditional | 01/14/1992SE |
| K910418 | Life-Trace Disposable Leg Plate Product # LT-100HGM · Traditional | 07/16/1991SE |
| K910282 | Medi-Trace(R) Disposable TocotonometerHFM · Traditional | 03/29/1991SE |
| K905130 | Fetal Monitoring Spiral ElectrodeHGP · Traditional | 01/29/1991SE |
| K904745 | Medi-Trace(R) Fetal Monitoring Spiral ElectrodeHGP · Traditional | 01/29/1991SE |
| K903973 | Gardosi Birthing CushionKNC · Traditional | 09/27/1990SE |
| K891193 | Medi-Trace Accu-Nate DeviceFPA · Traditional | 09/19/1989SE |
| K891192 | Medi-Trace Thermal Video Film PaperLMD · Traditional | 04/06/1989SE |
| K864722 | Medi-Trace Infant ElectrodeDRX · Traditional | 02/10/1987SE |
| K843580 | Medi-Trace Transduc Phys Pressure MonitoDRS · Traditional | 05/28/1985SE |
| K834445 | Medi-Trace Quikset DX Diag. Elect-DRX · Traditional | 04/01/1984SE |
| K822750 | Medi-Trace 5' Offset ElectrodeDRX · Traditional | 11/01/1982SE |
| K821137 | Meditrace Pellet ElectrodeDRX · Traditional | 05/18/1982SE |
| K820457 | Medi-Trace Physiological Pressure TransDRS · Traditional | 03/12/1982SE |
| K811410 | Medi-TraceKRA · Traditional | 06/12/1981SE |
| K801829 | Medi-Trace Disp. Flushing Dev./MonitorKRA · Traditional | 08/27/1980SE |
| K801828 | Medi-Trace Disp. Stopcocks/Physio. PressDTL · Traditional | 08/27/1980SE |
| K801322 | Medi-Trace Disp. Lines for Physio. PressDQO · Traditional | 06/30/1980SE |
| K801321 | Package for Medi-Trace Physiological PreDQO · Traditional | 06/30/1980SE |
| K800706 | Medi-Trace Disposable Domes/MonitoringDRS · Traditional | 04/16/1980SE |
| K800705 | Medi-Trace Transducers/Physiolog. MonitoDRS · Traditional | 04/16/1980SE |
| K790818 | Medi-Trace EEG CremeGYB · Traditional | 06/05/1979SE |
| K781493 | EEG GelGYB · Traditional | 04/17/1979SE |
| K781963 | Electrodes, Offset and DXDRX · Traditional | 12/19/1978SE |
| K781494 | EEG Lead AssemblyGXY · Traditional | 10/31/1978SE |
| K770623 | Conductive CREAM-500GYB · Traditional | 04/08/1977SE |
| K770622 | Conductivity Gel W/Potassium ChlorideGYB · Traditional | 04/07/1977SE |