Device, Monitoring, Intracranial Pressure
Regulation 882.1620
1510(k)s in 12 months (105 all time)
3recalls in 12 months (52 all time)
47recalls that name a 510(k)
Top companies in GWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 8 | 26 |
| Codman & Shurtleff, Inc. | 9 | 12 |
| Innerspace, Inc. | 7 | 0 |
| Raumedic AG | 6 | 0 |
| Sophysa | 3 | 3 |
| Integra Neurosciences | 5 | 0 |
| Metatech Corp. | 5 | 0 |
| Camino Laboratories, Inc. | 4 | 0 |
| Cma Microdialysis AB | 4 | 0 |
| Camino Neurocare, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2002 | K022553 | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L Integra Neurosciences | GWM |
| May 20, 2002 | K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP Medex, Inc. | GWM |
| Mar 21, 2002 | K020558 | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE Integra Neurosciences | GWM |
| Feb 20, 2002 | K013930 | NEUROSENSOR Novus Monitoring, Ltd., GB | GWM |
| Jun 28, 2001 | K010422 | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER Innerspace, Inc. | GWM |
| Jun 28, 2001 | K003759 | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR Aesculap, Inc. | GWM |
| Jun 15, 2001 | K003905 | ACTI-ICP MONITORING SYSTEM Innerspace, Inc. | GWM |
| Nov 24, 2000 | K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE Integra Neurosciences | GWM |
| Nov 2, 2000 | K002392 | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V Integra Neurocare, LLC | GWM |
| Oct 15, 1999 | K992591 | CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS Codman & Shurtleff, Inc. | GWM |
| Jul 14, 1999 | K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS Diametrics Medical, Ltd., GB | GWM |
| Jul 9, 1999 | K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT Johnson & Johnson Professionals, Inc. | GWM |
| Jan 26, 1999 | K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL Medtronic PS Medical | GWM |
| Sep 10, 1998 | K982702 | VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD Camino Neurocare, Inc. | GWM |
| Aug 18, 1998 | K981846 | PARENCHYMAL BOLT PRESSURE MONITORING KIT Camino Neurocare, Inc. | GWM |
| Jan 9, 1998 | K974088 | CODMAN INTRACRANIAL BOLT Johnson & Johnson Professionals, Inc. | GWM |
| Dec 20, 1996 | K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) Camino Neurocare, Inc. | GWM |
| Oct 26, 1995 | K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 Johnson & Johnson Professionals, Inc. | GWM |
| Sep 26, 1995 | K931609 | CHARTR ENG SYSTEM Ics Medical Corp. | GWM |
| Mar 1, 1995 | K940648 | CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER Cordis Corp. | GWM |
| Dec 7, 1994 | K943987 | OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE Innerspace Medical, Inc. | GWM |
| Mar 7, 1994 | K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER Codman & Shurtleff, Inc. | GWM |
| Apr 15, 1993 | K930221 | CAMINO VENTRICULAR TRANSDUCER ACCESSORY Camino Laboratories, Inc. | GWM |
| Mar 25, 1992 | K912139 | MODEL 704 Ivy Biomedical Systems, Inc. | GWM |
| Jan 17, 1992 | K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM Camino Laboratories, Inc. | GWM |
| Jul 3, 1990 | K884823 | TRANSPAC(R) II, DISPOSABLE TRANSDUCER Abbott Laboratories | GWM |
| Feb 23, 1990 | K896834 | MODEL BT-1 FOT BOLT INSTALLATION KIT Pearl Instruments Corp. | GWM |
| Nov 22, 1989 | K893395 | MINI-MONITOR J7000 ICP Ladd Research Industries, Inc. | GWM |
| Apr 26, 1989 | K890468 | MODEL FT-100 INTRACRANIAL PRESSURE MONITOR Pearl Instruments Corp. | GWM |
| Oct 27, 1988 | K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER Metatech Corp. | GWM |
| Sep 22, 1988 | K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT Metatech Corp. | GWM |
| Sep 8, 1988 | K882552 | METATECH ROBINSON BOLT ACCESSORY Metatech Corp. | GWM |
| Aug 29, 1988 | K883115 | PMT SUBARACHNOID SCREW, MODEL NO.1350-2 Pmt Corp. | GWM |
| Jul 18, 1988 | K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET Metatech Corp. | GWM |
| May 4, 1988 | K881183 | VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H Camino Laboratories, Inc. | GWM |
| Mar 28, 1988 | K880154 | METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM Metatech Corp. | GWM |
| Feb 26, 1987 | K862820 | LADD/STERITEK ICP MONITOR, CAT. NO. P3000 Ladd Research Industries, Inc. | GWM |
| Oct 14, 1986 | K863479 | MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL Medical Measurements, Inc. | GWM |
| Oct 6, 1986 | K853770 | CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT Codman & Shurtleff, Inc. | GWM |
| Jun 9, 1986 | K862012 | LADD MEDICAL S-2000 Ladd Research Industries, Inc. | GWM |
| Feb 20, 1986 | K853864 | INTRACRANIAL PRESSURE MONITORING KIT 070 Camino Laboratories, Inc. | GWM |
| Dec 27, 1985 | K854657 | INTRACRANIAL PRESSURE MONITORING CUP CATHETERS Cordis Corp. | GWM |
| Aug 16, 1985 | K844566 | ICP MONITOR MODEL 1000 Advanced Ultrasonic Testing & Research Corp. | GWM |
| Apr 4, 1984 | K840999 | PHILLY INFANT BOLT Philadelphia Medical Specialties | GWM |
| Feb 28, 1984 | K840003 | DISPOSABLE ICP KIT DIFF. SIZES Codman & Shurtleff, Inc. | GWM |
| Nov 16, 1982 | K822864 | INTRACRANIAL PRESSURE MONITORING DEVICE Medex, Inc. | GWM |
| Sep 14, 1982 | K822636 | CLASS II DEVICE FOR I.C.P. MONITORING Philadelphia Medical Specialties | GWM |
| Dec 18, 1981 | K813440 | PHILLY BOLT Philadelphia Medical Specialties | GWM |
| Nov 12, 1980 | K802149 | TM-5 INTRACRANIAL PRESSURE MONITOR Nicolet Biomedical Instruments | GWM |
| Oct 31, 1980 | K802138 | CHEEK TOOL SET Codman & Shurtleff, Inc. | GWM |
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