Product code GWM— Neurology
CMA CEREBRAL TISSUE MONITORING SYSTEM
- Advisory panel
- Neurology
- Total cleared
- 105
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GWM
1–100 of 105- K252241 — Pressio 3 Multi-parameter Neuromonitoring System
- K250285 — 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
- K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
- K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- K201989 — B4C System
- K210993 — CereLink ICP Monitor
- K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
- K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
- K200456 — Becker External Drainage and Monitoring System
- K182073 — BcSs-PICNI-2000 Sensor
- K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable
- K172209 — AURA ICP MONITORING SYSTEM
- K173192 — 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
- K171666 — MPR2 logO DATALOGGER
- K162108 — Pressio 2 ICP Monitoring System
- K161010 — HICP200 Patient/Monitor Interconnect Cable
- K153347 — 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
- K152670 — DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
- K141869 — QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
- K133754 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
- K130529 — RAUMEDIC-PTO-MONITORING-SYSTEM
- K131184 — INTEGRA LICOX PTO2 MONITOR
- K121573 — INTEGRA CAMINO ICP MONITOR
- K121159 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
- K113088 — HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
- K120252 — RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
- K112017 — RAUMEDIC ICP MONITORING SYSTEM
- K103206 — RAUMEDIC- ICP-MONITORING SYSTEM
- K102077 — MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
- K102875 — CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
- K101133 — SENSOMETRICS SOFTWARE
- K083378 — SYNERGY
- K071984 — MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
- K072379 — MPS OXIPORT AND MPS OXIPORT PLUS
- K071505 — MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
- K062584 — PRESSIO ICP MONITORING SYSTEM
- K061640 — INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
- K053244 — LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
- K060554 — CMA CEREBRAL TISSUE MONITORING SYSTEM
- K051599 — NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
- K050702 — NEUROSYSTEMS 1TM MONITOR
- K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
- K041838 — MPS (OR MPS-T)
- K042728 — CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
- K040235 — LICOX PMO BRAIN MONITORING SYSTEM
- K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
- K031086 — CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
- K022638 — NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
- K020285 — CMA CEREBRAL TISSUE MONITORING SYSTEM
- K013705 — ACT III VENTRICULAR CATHETER
- K022553 — CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
- K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
- K020558 — LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
- K013930 — NEUROSENSOR
- K003759 — AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
- K010422 — ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
- K003905 — ACTI-ICP MONITORING SYSTEM
- K002765 — LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
- K002392 — VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
- K992591 — CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
- K980380 — NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
- K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
- K983799 — MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
- K982702 — VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
- K981846 — PARENCHYMAL BOLT PRESSURE MONITORING KIT
- K974088 — CODMAN INTRACRANIAL BOLT
- K962928 — COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
- K945585 — COMAN(R) CU-11 MODEL NUMBER 82-6634
- K931609 — CHARTR ENG SYSTEM
- K940648 — CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
- K943987 — OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
- K914479 — MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
- K930221 — CAMINO VENTRICULAR TRANSDUCER ACCESSORY
- K912139 — MODEL 704
- K914735 — VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
- K884823 — TRANSPAC(R) II, DISPOSABLE TRANSDUCER
- K896834 — MODEL BT-1 FOT BOLT INSTALLATION KIT
- K893395 — MINI-MONITOR J7000 ICP
- K890468 — MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
- K883881 — MODIFIED MODEL 2001 FIBER OPTICS CATHETER
- K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
- K882552 — METATECH ROBINSON BOLT ACCESSORY
- K883115 — PMT SUBARACHNOID SCREW, MODEL NO.1350-2
- K882286 — EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
- K881183 — VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
- K880154 — METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
- K862820 — LADD/STERITEK ICP MONITOR, CAT. NO. P3000
- K863479 — MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
- K853770 — CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
- K862012 — LADD MEDICAL S-2000
- K853864 — INTRACRANIAL PRESSURE MONITORING KIT 070
- K854657 — INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
- K844566 — ICP MONITOR MODEL 1000
- K840999 — PHILLY INFANT BOLT
- K840003 — DISPOSABLE ICP KIT DIFF. SIZES
- K822864 — INTRACRANIAL PRESSURE MONITORING DEVICE
- K822636 — CLASS II DEVICE FOR I.C.P. MONITORING
- K813440 — PHILLY BOLT
- K802149 — TM-5 INTRACRANIAL PRESSURE MONITOR
- K802137 — CHEEK EPIDURAL SCREW
Data sourced from openFDA. This site is unofficial and independent of the FDA.