Clearpoint Neuro Inc

FDA Filings

This page includes the latest FDA filings for Clearpoint Neuro Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQCLPTDUNS 959181160
FDA Registration(s)
Registration Number1125732
FEI Number3002838670
NameClearPoint Neuro Inc.
Owner & OperatorClearPoint Neuro, Inc.
Contact Address5 Musick --
Irvine CA 92618 US
Official Correspondent
  • Peter - Piferi
  • x-949-9006833-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Musick
Irvine, CA 92618 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ClearPoint Neuro, Inc.
ClearPoint System2022-09-16
CLEARPOINT NEURO, INC.
ClearPoint Array CPA-SFW-11-112022-05-03
CLEARPOINT NEURO, INC.
SMARTFrame Array NGS-SFA-DG-032022-04-22
CLEARPOINT NEURO, INC.
SmartFrame NGS-SF-04-112022-02-08
CLEARPOINT NEURO, INC.
ClearPoint NGS-XG-062022-02-04
CLEARPOINT NEURO, INC.
ClearPoint CP-INHFF-342-012021-08-20
CLEARPOINT NEURO, INC.
ClearPoint CP-MPHFF-132-012021-08-20
CLEARPOINT NEURO, INC.
Array CP-NGS-SFA-MRDK2021-07-22
CLEARPOINT NEURO, INC.
Array CP-NGS-SFA-MRBH2021-07-22
CLEARPOINT NEURO, INC.
Array NGS-SFA-03-22021-07-22
CLEARPOINT NEURO, INC.
SmartFrame Array NGS-SFA-02-22021-07-22
CLEARPOINT NEURO, INC.
ClearPoint CP-INHFF-132-012021-04-26
CLEARPOINT NEURO, INC.
Array CP-NGS-SFA-ORMR2021-04-15
CLEARPOINT NEURO, INC.
SmartTip NGS-DB-45-S2021-04-15
CLEARPOINT NEURO, INC.
SmartFrame Array Thumbwheel Extension 2021-04-15
CLEARPOINT NEURO, INC.
SmartFrame Array 2021-04-15
CLEARPOINT NEURO, INC.
ClearPoint Array Workstation 2021-04-15
CLEARPOINT NEURO, INC.
Array NGS-SFA-01-22021-04-15
CLEARPOINT NEURO, INC.
ClearPoint Array 2021-04-15
CLEARPOINT NEURO, INC.
ClearPoint CP-INHFF-242-012021-02-22
CLEARPOINT NEURO, INC.
ClearPoint CP-INHFF-422-012021-02-22
CLEARPOINT NEURO, INC.
ClearPoint CP-HFF-222-01 2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-HFF-212-01 2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP- HFF-211-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG TwistPoint Kit w/TE-7 CP-NGS-11-TP45-XG-72021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG TwistPoint Kit w/TE-5 Fr CP-NGS-11-TP45-XG-52021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG Exchangeable Drill Guide-6.0 mm NGS-XG-052021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG Exchangeable Device Guide-3.2 mm NGS-XG-042021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG Exchangeable Device Guide-2.5 mm NGS-XG-032021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG-7 Fr NGS-SF-02-11-72021-02-01
CLEARPOINT NEURO, INC.
SmartFrame XG-5 Fr NGS-SF-02-11-52021-02-01
CLEARPOINT NEURO, INC.
ClearPoint 7 Fr Accessory Kit NGS-AK-01-11-72021-02-01
CLEARPOINT NEURO, INC.
ClearPoint 5 Fr Accessory Kit NGS-AK-01-11-52021-02-01
CLEARPOINT NEURO, INC.
Larson Bladed Lancet NGS-BL-012021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-SFW-11-2022021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-SFW-11-2012021-02-01
CLEARPOINT NEURO, INC.
V-TAG NGS-VT-012021-02-01
CLEARPOINT NEURO, INC.
ClearPoint PURSUIT MCA-66-2502021-02-01
CLEARPOINT NEURO, INC.
ClearPoint PURSUIT MCA-66-3002021-02-01
CLEARPOINT NEURO, INC.
ClearPoint PURSUIT MCA-59-2502021-02-01
CLEARPOINT NEURO, INC.
ClearPoint PURSUIT MCA-59-3002021-02-01
CLEARPOINT NEURO, INC.
ClearPoint PURSUIT MCA-53-2502021-02-01
CLEARPOINT NEURO, INC.
ClearPoint PURSUIT MCA-53-3002021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-NGS-11-SKM-XG2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-NGS-11-CG45-XG2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-NGS-11-TP45-XG2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-NGS-11-SCM2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-NGS-11-SKM2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-SFW-11-1622021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-SFW-11-202021-02-01
CLEARPOINT NEURO, INC.
MRI Interventions NGS-HX-M62021-02-01
CLEARPOINT NEURO, INC.
MRI Interventions NGS-BD-M62021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-EXT-22-012021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-EXT-21-012021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-MON-022021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-WRK-022021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-WRK-032021-02-01
CLEARPOINT NEURO, INC.
ClearPoint CP-MON-032021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-082021-02-01
CLEARPOINT NEURO, INC.
Smartflow NGS-NC-072021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-062021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-052021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-042021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-032021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-022021-02-01
CLEARPOINT NEURO, INC.
SmartFlow NGS-NC-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-RS-032021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-RS-022021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-RS-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-CG-012021-02-01
CLEARPOINT NEURO, INC.
ClearPoint NGS-BM-052021-02-01
CLEARPOINT NEURO, INC.
SmartTip NGS-DB-452021-02-01
CLEARPOINT NEURO, INC.
SmartTip NGS-DB-012021-02-01
CLEARPOINT NEURO, INC.
SmartTwist NGS-HD-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-SK-01-112021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-SM-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-XG-022021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-XG-012021-02-01
CLEARPOINT NEURO, INC.
MRII NGS-EC-16X24-062021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-GT-062021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-GT-052021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-GT-042021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-GT-032021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-GT-022021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-GT-012021-02-01
CLEARPOINT NEURO, INC.
ClearPoint NGS-PD-052021-02-01
CLEARPOINT NEURO, INC.
ClearPoint NGS-PD-042021-02-01
CLEARPOINT NEURO, INC.
ClearPoint NGS-PD-03-L2021-02-01
CLEARPOINT NEURO, INC.
ClearPoint NGS-PD-032021-02-01
CLEARPOINT NEURO, INC.
ClearPoint NGS-PD-02-L2021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-TE-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-HC-012021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-AK-01-112021-02-01
CLEARPOINT NEURO, INC.
SmartGrid NGS-SG-01-112021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-SF-03-112021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-SF-02-112021-02-01
CLEARPOINT NEURO, INC.
SmartFrame NGS-SF-01-112021-02-01
CLEARPOINT NEURO, INC.
SmartFrame CP-NGS-11-TE-CG452021-02-01
CLEARPOINT NEURO, INC.
SmartFrame CP-NGS-11-TE-TP452021-02-01
CLEARPOINT NEURO, INC.
SmartFrame CP-NGS-11-HC-TP452021-02-01
CLEARPOINT NEURO, INC.
SmartFrame CP-NGS-11-HC-TP32-E2021-02-01
ClearPoint Neuro, Inc.
ClearPoint Array System2021-01-22
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Inflexion Head Frame2019-12-03
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Voyager Trajectory Guide2019-12-03
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
V-Tag2019-03-12
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint Pursuit2018-12-17
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System2018-12-17
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System2018-12-17
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Clearpoint System2017-11-06
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Clearpoint System2017-11-06
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Clearpoint System2016-11-04
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Clearpoint System2016-11-04
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SmartTwist MRI Hand Drill, SmartTip Drill Bit Kit2016-11-04
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SmartTwist MRI Hand Drill, SmartTip Drill Bit Kit2016-11-04
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SmartTwist MRII Hand Drill, SmartTip MRII Drill Bit Kit, 4.5mm, 6.0mm2015-12-21
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System2015-12-21
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System2015-12-21
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Brain Array Siemens 3T2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Brain Array GE 1.5T2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTGrid2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTFrame2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System 3T2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTGrid2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTFrame2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System 3T2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Braine Array Siemens 1.5T2011-11-01
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SmartFlow2011-04-28
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTGrid2010-07-07
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTFrame2010-07-07
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System2010-07-07
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTGrid2010-07-07
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
SMARTFrame2010-07-07
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
ClearPoint System2010-07-07
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
Head Fixation Arc2009-11-13
ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]
MRI Neuro Drape2009-11-13

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