GWM

Product Code: GWM


Products Classified as GWM

3644Device, Monitoring, Intracranial PressureIntracranial Pressure Monitoring Device.

Total Product Life Cycle (TPLC) Devices

3644Device, Monitoring, Intracranial PressureIntracranial Pressure Monitoring Device.

FDA Consensus Standards

Device, Monitoring, Intracranial Pressure [34074]21 CFR §882.1620 🔎
Device, Monitoring, Intracranial Pressure [36835]21 CFR §882.1620 🔎

Pre-market Notifications for GWM

K210993CereLink ICP MonitorIntegra LifeSciences Production Corporation
K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.
K201118Exacta External Drainage And Monitoring System, Exacta Pole With Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelMedtronic, Inc.
K200630Medtronic External Drainage And Monitoring System, Medtronic External Drainage And Monitoring System, Becker Replacement Drainage BagsMedtronic, Inc.
K200456Becker External Drainage And Monitoring SystemMedtronic, Inc.
K183406CereLink ICP Monitor, CereLink ICP Extension CableIntegra LifeSciences Corp.
K182073BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A.
K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc
K172209AURA ICP MONITORING SYSTEMBranchpoint Technologies, INC.
K171666MPR2 LogO DATALOGGERRaumedic AG
K162108Pressio 2 ICP Monitoring SystemSOPHYSA, SA
K161010HICP200 Patient/Monitor Interconnect CableInnerSpace Neuro Solutions, Inc.
K153347Codman 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 KitCODMAN & SHURTLEFF, INC.
K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL
K141869QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KITHEMEDEX INCORPORATED

Global Unique Device Identification Database

10381780023661Device, Monitoring, Intracranial Pressure
00382830047531Device, Monitoring, Intracranial Pressure
10381780258049Device, Monitoring, Intracranial Pressure
10381780025511Device, Monitoring, Intracranial Pressure
10381780023630Device, Monitoring, Intracranial Pressure
10381780023623Device, Monitoring, Intracranial Pressure
00382830002943Device, Monitoring, Intracranial Pressure
00613994857996DEVICE, MONITORING, INTRACRANIAL PRESSURE
00613994445407DEVICE, MONITORING, INTRACRANIAL PRESSURE
00613994445384DEVICE, MONITORING, INTRACRANIAL PRESSURE
00613994445377DEVICE, MONITORING, INTRACRANIAL PRESSURE
00613994445360DEVICE, MONITORING, INTRACRANIAL PRESSURE
20613994430537DEVICE, MONITORING, INTRACRANIAL PRESSURE
00613994430526DEVICE, MONITORING, INTRACRANIAL PRESSURE
00613994318060DEVICE, MONITORING, INTRACRANIAL PRESSURE

Maude Adverse Events

EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC MEXICO2020-03-27
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-03-27
POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT(DESIGN AND PRODUCTION) NATUS MEDICAL INCORPORATED2020-03-26
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC MEXICO2020-03-23
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC MEXICO2020-03-23
EDM LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-03-18
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2020-03-13
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2020-03-13
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2020-03-13
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2020-03-13
OLM INTRACRANIAL PRESSURE MONITORING KITNATUS MEDICAL INCORPORATED2020-03-06
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2020-03-06
CAMINO CAM02 SENSOR BOARDNATUS MEDICAL INCORPORATED2020-02-26
SUBDURAL POST CRANIOTOMY ICP MONITORING KINATUS MEDICAL INCORPORATED2020-02-13
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-02-12
OLM INTRACRANIAL PRESSURE MONITORING KITNATUS MEDICAL INCORPORATED2020-02-11
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-02-10
OLM INTRACRANIAL PRESSURE MONITORING KITNATUS MEDICAL INCORPORATED2020-02-07
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-01-23
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-01-23
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2020-01-10
NEUROVENT-PRAUMEDIC AG2020-01-08
LICOXINTEGRA LIFESCIENCES (IRELAND) LIMITED2020-01-03
PRESSIO ICP AND ICT MONITORING KIT, VENTRICULAR TUNNELINGSOPHYSA2019-11-28
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2019-11-27
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2019-11-27
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2019-11-27
CAMINO ICPNATUS NEURO INCORPORATED2019-11-26
CAMINO ICPNATUS NEURO INCORPORATED2019-11-26
CAMINO ICPNATUS NEURO INCORPORATED2019-11-26
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-11-25
CAMINO ICPNATUS NEURO INCORPORATED2019-11-21
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-11-20
EDM LUMBAR DRAINAGE KITMEDTRONIC NEUROSURGERY2019-11-20
NEUROMONITOR BASIC KITRAYNHAM2019-11-18
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-11-15
MICROSENSOR KIT W/ SKULL BOLTRAYNHAM2019-11-14
NEUROMONITOR BASIC KITRAYNHAM2019-11-13
UNKNOWN MICROSENSORINTEGRA LIFESCIENCES SWITZERLAND SAR2019-11-11
EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-11-06
NEUROVENT-PRAUMEDIC AG2019-11-06
DIRECTLINK ICP MODULEINTEGRA LIFESCIENCES SWITZERLAND SAR2019-11-04
ICP SENSOR CATHETER KITRAYNHAM2019-11-01
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-11-01
MICROSENSOR VENTRICULAR CATHETER KITRAYNHAM2019-10-31
MICROSENSOR KIT W/ SKULL BOLTRAYNHAM2019-10-29
CAMINO ICPNATUS NEURO INCORPORATED2019-10-29
PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.INTEGRA NEUROSCICENCS IMPLANTS SA2019-10-29
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-10-28
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEMMEDTRONIC NEUROSURGERY2019-10-28
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