Graphic Controls Corp.
Mchenry, IL, US
Graphic Controls Corp. appears in FDA device records in Mchenry, IL. FDA records list 55 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 55
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Graphic Controls Corp. between 1977 and 1998. The busiest year on record is 1995, with 9. The most recent is 1998, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 2 |
| 1979 | 2 |
| 1980 | 6 |
| 1981 | 1 |
| 1982 | 3 |
| 1984 | 1 |
| 1985 | 1 |
| 1987 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 9 |
| 1996 | 8 |
| 1997 | 3 |
| 1998 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | DRX | Substantially Equivalent | |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | MKJ | Substantially Equivalent | |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | KXO | Substantially Equivalent | |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE | MKJ | Substantially Equivalent | |
| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | MKJ | Substantially Equivalent | |
| K964387 | POINT OF USE II SHARPS-A-GATOR | MMK | Substantially Equivalent | |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | KXO | Substantially Equivalent | |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | DRX | Substantially Equivalent | |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | DRX | Substantially Equivalent | |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | DRX | Substantially Equivalent | |
| K955923 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL | MKJ | Substantially Equivalent | |
| K955882 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS | MKJ | Substantially Equivalent | |
| K955828 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS | MKJ | Substantially Equivalent | |
| K955597 | MEDI-TRACE DEFIB PADS | GYB | Substantially Equivalent | |
| K961395 | MEDI-TRACE RADIOLUCENT | DRX | Substantially Equivalent | |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | KXO | Substantially Equivalent | |
| K950485 | GRAPHIC CONTROLS PROTRACE ECG ELECTRODE | DRX | Substantially Equivalent | |
| K945479 | MEDI-TRACE(R) 500 ECG ELECTRODE | DRX | Substantially Equivalent | |
| K950489 | GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE | DRX | Substantially Equivalent | |
| K950488 | GRAPHIC CONTROLS BIOTAC ECO ELECTRODE | DRX | Substantially Equivalent | |
| K950782 | MEDI-TRAC EEG ELECTRODE | GXY | Substantially Equivalent | |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | KXO | Substantially Equivalent | |
| K950487 | GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE | DRX | Substantially Equivalent | |
| K950486 | GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE | DRX | Substantially Equivalent | |
| K945214 | MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE | DRX | Substantially Equivalent | |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | HGP | Substantially Equivalent | |
| K933365 | BABISTICK | FMK | Substantially Equivalent | |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | FOK | Substantially Equivalent | |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | KXO | Substantially Equivalent | |
| K910418 | LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 | HGM | Substantially Equivalent | |
| K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | HFM | Substantially Equivalent | |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | HGP | Substantially Equivalent | |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | HGP | Substantially Equivalent | |
| K903973 | GARDOSI BIRTHING CUSHION | KNC | Substantially Equivalent | |
| K891193 | MEDI-TRACE ACCU-NATE DEVICE | FPA | Substantially Equivalent | |
| K891192 | MEDI-TRACE THERMAL VIDEO FILM PAPER | LMD | Substantially Equivalent | |
| K864722 | MEDI-TRACE INFANT ELECTRODE | DRX | Substantially Equivalent | |
| K843580 | MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO | DRS | Substantially Equivalent | |
| K834445 | MEDI-TRACE QUIKSET DX DIAG. ELECT- | DRX | Substantially Equivalent | |
| K822750 | MEDI-TRACE 5' OFFSET ELECTRODE | DRX | Substantially Equivalent | |
| K821137 | MEDITRACE PELLET ELECTRODE | DRX | Substantially Equivalent | |
| K820457 | MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS | DRS | Substantially Equivalent | |
| K811410 | MEDI-TRACE | KRA | Substantially Equivalent | |
| K801829 | MEDI-TRACE DISP. FLUSHING DEV./MONITOR | KRA | Substantially Equivalent | |
| K801828 | MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS | DTL | Substantially Equivalent | |
| K801322 | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS | DQO | Substantially Equivalent | |
| K801321 | PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE | DQO | Substantially Equivalent | |
| K800706 | MEDI-TRACE DISPOSABLE DOMES/MONITORING | DRS | Substantially Equivalent | |
| K800705 | MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO | DRS | Substantially Equivalent | |
| K790818 | MEDI-TRACE EEG CREME | GYB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- MKJAutomated External Defibrillators (Non-Wearable)
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- MMKContainer, Sharps
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- GYBMedia, Electroconductive
- KXOMonitor, Pressure, Intrauterine
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- FOKPad, Neonatal Eye
- FPASet, Administration, Intravascular
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- LMDSystem, Digital Image Communications, Radiological
- HGMSystem, Monitoring, Perinatal
- KNCTable, Obstetric (And Accessories)
- DRSTransducer, Blood-Pressure, Extravascular
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain