Integra Neurosciences - FDA 510(k) Cleared Devices
Recent clearances: AURAGEN CORTICAL SURFACE ELECTRODES, NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100, CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Integra Neurosciences Neurology ✕
7 devices
Cleared
Oct 10, 2008
AURAGEN CORTICAL SURFACE ELECTRODES
Neurology
63d
Cleared
May 11, 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING...
Neurology
51d
Cleared
May 14, 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
Neurology
37d
Cleared
Aug 23, 2002
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Neurology
21d
Cleared
Aug 20, 2002
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING,...
Neurology
18d
Cleared
Mar 21, 2002
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
Neurology
29d
Cleared
Nov 24, 2000
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC...
Neurology
80d