| Pressio 3 Multi-parameter Neuromonitoring System (K252241) | Sophysa | 2026-04-10 |
| NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (K250285) | Raumedic AG | 2025-08-29 |
| B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024-07-18 |
| CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890) | Integra Lifesciences Production Corporation | 2024-02-04 |
| B4C System (K201989) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021-10-08 |
| CereLink ICP Monitor (K210993) | Integra Lifesciences Production Corporation | 2021-04-30 |
| Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (K201118) | Medtronic, Inc. | 2020-05-26 |
| Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630) | Medtronic, Inc. | 2020-04-09 |
| Becker External Drainage and Monitoring System (K200456) | Medtronic, Inc. | 2020-03-26 |
| BcSs-PICNI-2000 Sensor (K182073) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019-10-17 |
| CereLink ICP Monitor, CereLink ICP Extension Cable (K183406) | Integra Lifesciences Corp. | 2019-01-11 |
| AURA ICP MONITORING SYSTEM (K172209) | Branchpoint Technologies, Inc. | 2018-05-18 |
| CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit (K173192) | Codman & Shurtleff, Inc. | 2017-11-08 |
| MPR2 logO DATALOGGER (K171666) | Raumedic AG | 2017-07-06 |
| Pressio 2 ICP Monitoring System (K162108) | Sophysa SA | 2017-04-17 |
| HICP200 Patient/Monitor Interconnect Cable (K161010) | Innerspace Neuro Solutions, Inc. | 2016-10-20 |
| Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit (K153347) | Codman & Shurtleff, Inc. | 2016-08-19 |
| DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables (K152670) | Medos International SARL | 2016-01-22 |
| QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT (K141869) | Hemedex Incorporated | 2014-10-10 |
| INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER (K133754) | Integra LifeSciences Corporation | 2014-03-06 |
| RAUMEDIC-PTO-MONITORING-SYSTEM (K130529) | Raumedic AG | 2013-10-25 |
| INTEGRA LICOX PTO2 MONITOR (K131184) | Integra Lifesciences Corp. | 2013-08-30 |
| INTEGRA CAMINO ICP MONITOR (K121573) | Intrgra Lifesciences Corporation | 2012-09-10 |
| INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER (K121159) | Integra Lifescience Corportation | 2012-07-20 |
| HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) (K113088) | Innerspace, Inc. | 2012-05-02 |
| RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM (K120252) | Raumedic AG | 2012-04-11 |
| RAUMEDIC ICP MONITORING SYSTEM (K112017) | Raumedic AG | 2011-10-11 |
| RAUMEDIC- ICP-MONITORING SYSTEM (K103206) | Raumedic AG | 2011-03-04 |
| MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM (K102077) | Cma Microdialysis AB | 2011-01-14 |
| CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C (K102875) | Integra LifeSciences Corporation | 2010-12-20 |
| SENSOMETRICS SOFTWARE (K101133) | Dpcom AS | 2010-11-18 |
| SYNERGY (K083378) | Innerspace, Inc. | 2009-09-29 |
| MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM (K071984) | Cma Microdialysis AB | 2008-06-27 |
| MPS OXIPORT AND MPS OXIPORT PLUS (K072379) | Innerspace, Inc. | 2008-04-29 |
| MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM (K071505) | Integra LifeSciences Corporation | 2007-08-06 |
| PRESSIO ICP MONITORING SYSTEM (K062584) | Sophysa SA | 2007-07-05 |
| INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM (K061640) | Integra LifeSciences Corporation | 2006-07-27 |
| LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT (K053244) | Integra Lifesciences Corp. | 2006-05-10 |
| CMA CEREBRAL TISSUE MONITORING SYSTEM (K060554) | Cma Microdialysis AB | 2006-05-02 |
| NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT (K051599) | Neurorecovery, Inc. | 2005-07-19 |
| NEUROSYSTEMS 1TM MONITOR (K050702) | Neurosystems, LLC | 2005-05-17 |
| NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 (K050720) | Integra Neurosciences | 2005-05-11 |
| MPS (OR MPS-T) (K041838) | Innerspace, Inc. | 2005-03-01 |
| CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM (K042728) | Novus Monitoring, Ltd. | 2004-10-22 |
| LICOX PMO BRAIN MONITORING SYSTEM (K040235) | Integra LifeSciences Corporation | 2004-04-20 |
| HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 (K032337) | Hemedex Incorporated | 2003-10-21 |
| CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 (K031086) | Integra Neurosciences | 2003-05-14 |
| NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT (K022638) | Neurorecovery, Inc. | 2002-10-31 |
| CMA CEREBRAL TISSUE MONITORING SYSTEM (K020285) | Cma Microdialysis AB | 2002-10-23 |
| ACT III VENTRICULAR CATHETER (K013705) | Innerspace, Inc. | 2002-09-09 |
| CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L (K022553) | Integra Neurosciences | 2002-08-20 |
| TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP (K020780) | Medex, Inc. | 2002-05-20 |
| LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE (K020558) | Integra Neurosciences | 2002-03-21 |
| NEUROSENSOR (K013930) | Novus Monitoring, Ltd. | 2002-02-20 |
| AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR (K003759) | Aesculap, Inc. | 2001-06-28 |
| ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER (K010422) | Innerspace, Inc. | 2001-06-28 |
| ACTI-ICP MONITORING SYSTEM (K003905) | Innerspace, Inc. | 2001-06-15 |
| LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE (K002765) | Integra Neurosciences | 2000-11-24 |
| VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V (K002392) | Integra Neurocare, LLC | 2000-11-02 |
| CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS (K992591) | Codman & Shurtleff, Inc. | 1999-10-15 |
| NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS (K980380) | Diametrics Medical, Ltd. | 1999-07-14 |
| CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (K991222) | Johnson & Johnson Professionals, Inc. | 1999-07-09 |
| MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL (K983799) | Medtronic PS Medical | 1999-01-26 |
| VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD (K982702) | Camino Neurocare, Inc. | 1998-09-10 |
| PARENCHYMAL BOLT PRESSURE MONITORING KIT (K981846) | Camino Neurocare, Inc. | 1998-08-18 |
| CODMAN INTRACRANIAL BOLT (K974088) | Johnson & Johnson Professionals, Inc. | 1998-01-09 |
| COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) (K962928) | Camino Neurocare, Inc. | 1996-12-20 |
| COMAN(R) CU-11 MODEL NUMBER 82-6634 (K945585) | Johnson & Johnson Professionals, Inc. | 1995-10-26 |
| CHARTR ENG SYSTEM (K931609) | Ics Medical Corp. | 1995-09-26 |
| CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER (K940648) | Cordis Corp. | 1995-03-01 |
| OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE (K943987) | Innerspace Medical, Inc. | 1994-12-07 |
| MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER (K914479) | Codman & Shurtleff, Inc. | 1994-03-07 |
| CAMINO VENTRICULAR TRANSDUCER ACCESSORY (K930221) | Camino Laboratories, Inc. | 1993-04-15 |
| MODEL 704 (K912139) | Ivy Biomedical Systems, Inc. | 1992-03-25 |
| VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM (K914735) | Camino Laboratories, Inc. | 1992-01-17 |
| TRANSPAC(R) II, DISPOSABLE TRANSDUCER (K884823) | Abbott Laboratories | 1990-07-03 |
| MODEL BT-1 FOT BOLT INSTALLATION KIT (K896834) | Pearl Instruments Corp. | 1990-02-23 |
| MINI-MONITOR J7000 ICP (K893395) | Ladd Research Industries, Inc. | 1989-11-22 |
| MODEL FT-100 INTRACRANIAL PRESSURE MONITOR (K890468) | Pearl Instruments Corp. | 1989-04-26 |
| MODIFIED MODEL 2001 FIBER OPTICS CATHETER (K883881) | Metatech Corp. | 1988-10-27 |
| EVENT MARKER & A SECOND PRESSURE TREND OUTPUT (K883518) | Metatech Corp. | 1988-09-22 |
| METATECH ROBINSON BOLT ACCESSORY (K882552) | Metatech Corp. | 1988-09-08 |
| PMT SUBARACHNOID SCREW, MODEL NO.1350-2 (K883115) | Pmt Corp. | 1988-08-29 |
| EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET (K882286) | Metatech Corp. | 1988-07-18 |
| VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H (K881183) | Camino Laboratories, Inc. | 1988-05-04 |
| METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM (K880154) | Metatech Corp. | 1988-03-28 |
| LADD/STERITEK ICP MONITOR, CAT. NO. P3000 (K862820) | Ladd Research Industries, Inc. | 1987-02-26 |
| MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL (K863479) | Medical Measurements, Inc. | 1986-10-14 |
| CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT (K853770) | Codman & Shurtleff, Inc. | 1986-10-06 |
| LADD MEDICAL S-2000 (K862012) | Ladd Research Industries, Inc. | 1986-06-09 |
| INTRACRANIAL PRESSURE MONITORING KIT 070 (K853864) | Camino Laboratories, Inc. | 1986-02-20 |
| INTRACRANIAL PRESSURE MONITORING CUP CATHETERS (K854657) | Cordis Corp. | 1985-12-27 |
| ICP MONITOR MODEL 1000 (K844566) | Advanced Ultrasonic Testing & Research Corp. | 1985-08-16 |
| PHILLY INFANT BOLT (K840999) | Philadelphia Medical Specialties | 1984-04-04 |
| DISPOSABLE ICP KIT DIFF. SIZES (K840003) | Codman & Shurtleff, Inc. | 1984-02-28 |
| INTRACRANIAL PRESSURE MONITORING DEVICE (K822864) | Medex, Inc. | 1982-11-16 |
| CLASS II DEVICE FOR I.C.P. MONITORING (K822636) | Philadelphia Medical Specialties | 1982-09-14 |
| PHILLY BOLT (K813440) | Philadelphia Medical Specialties | 1981-12-18 |
| TM-5 INTRACRANIAL PRESSURE MONITOR (K802149) | Nicolet Biomedical Instruments | 1980-11-12 |
| CHEEK TOOL SET (K802138) | Codman & Shurtleff, Inc. | 1980-10-31 |