GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Innerspace, Inc. and Raumedic AG.

105
Total
105
Cleared
149d
Avg days
1978
Since
105 devices
25–48 of 105
Cleared May 02, 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
K113088
Innerspace, Inc.
Neurology · 196d
Cleared Apr 11, 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252
Raumedic AG
Neurology · 75d
Cleared Oct 11, 2011
RAUMEDIC ICP MONITORING SYSTEM
K112017
Raumedic AG
Neurology · 89d
Cleared Mar 04, 2011
RAUMEDIC- ICP-MONITORING SYSTEM
K103206
Raumedic AG
Neurology · 123d
Cleared Jan 14, 2011
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K102077
Cma Microdialysis AB
Neurology · 175d
Cleared Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875
Integra LifeSciences Corporation
Neurology · 80d
Cleared Nov 18, 2010
SENSOMETRICS SOFTWARE
K101133
Dpcom AS
Neurology · 210d
Cleared Sep 29, 2009
SYNERGY
K083378
Innerspace, Inc.
Neurology · 319d
Cleared Jun 27, 2008
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K071984
Cma Microdialysis AB
Neurology · 344d
Cleared Apr 29, 2008
MPS OXIPORT AND MPS OXIPORT PLUS
K072379
Innerspace, Inc.
Neurology · 249d
Cleared Aug 06, 2007
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505
Integra LifeSciences Corporation
Neurology · 66d
Cleared Jul 05, 2007
PRESSIO ICP MONITORING SYSTEM
K062584
Sophysa SA
Neurology · 307d
Cleared Jul 27, 2006
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640
Integra LifeSciences Corporation
Neurology · 45d
Cleared May 10, 2006
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
K053244
Integra Lifesciences Corp.
Neurology · 170d
Cleared May 02, 2006
CMA CEREBRAL TISSUE MONITORING SYSTEM
K060554
Cma Microdialysis AB
Neurology · 62d
Cleared Jul 19, 2005
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K051599
Neurorecovery, Inc.
Neurology · 33d
Cleared May 17, 2005
NEUROSYSTEMS 1TM MONITOR
K050702
Neurosystems, LLC
Neurology · 60d
Cleared May 11, 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
K050720
Integra Neurosciences
Neurology · 51d
Cleared Mar 01, 2005
MPS (OR MPS-T)
K041838
Innerspace, Inc.
Neurology · 237d
Cleared Oct 22, 2004
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K042728
Novus Monitoring, Ltd.
Neurology · 21d
Cleared Apr 20, 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235
Integra LifeSciences Corporation
Neurology · 78d
Cleared Oct 21, 2003
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
K032337
Hemedex Incorporated
Neurology · 84d
Cleared May 14, 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086
Integra Neurosciences
Neurology · 37d
Cleared Oct 31, 2002
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
K022638
Neurorecovery, Inc.
Neurology · 84d