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.

USA

NASDAQ

CLPT

DUNS 959181160

FDA Registration(s)

• Registration Number: 1125732
• FEI Number: 3002838670
• Name: ClearPoint Neuro Inc.
• Owner & Operator: ClearPoint Neuro, Inc.
• Contact Address: 5 Musick --; Irvine CA 92618 US
• Official Correspondent:
  • Peter - Piferi
  • x-949-9006833-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5 Musick ; Irvine, CA 92618 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00850047354112 Clearpoint Neuro, Inc.	SmartFlow NGS-NC-02-EE	2024-12-03
GUDID 00850047354105 Clearpoint Neuro, Inc.	SmartFlow NGS-NC-01-EE	2024-12-03
GUDID 00850376007925 Clearpoint Neuro, Inc.	Bone Anchor NGS-BA-01	2024-05-24
GUDID 00850047354075 Clearpoint Neuro, Inc.	SMARTFrame Expanded Accessory Kit, 7 Fr NGS-EAK-01-11-7	2024-05-24
GUDID 00850047354068 Clearpoint Neuro, Inc.	SMARTFrame Expanded Accessory Kit, 5 Fr NGS-EAK-01-11-5	2024-05-24
GUDID 00850047354051 Clearpoint Neuro, Inc.	ClearPoint Mobile Equipment Cart CP-MEC-01	2024-05-24
GUDID 00850376007956 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-DG-07	2024-03-19
GUDID 00850376007949 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-CP-01	2024-03-19
GUDID 00850376007932 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-XG-01	2024-03-19
GUDID 00850047354044 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-BSF-01	2024-03-19
GUDID 00850047354037 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-DS-01	2024-03-19
GUDID 00850047354020 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-SM-01	2024-03-19
GUDID 00850047354013 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-SK-01	2024-03-19
GUDID 00850047354006 Clearpoint Neuro, Inc.	SmartFrame OR NGS-SFOR-DG-06	2024-03-19
GUDID 00850376007901 Clearpoint Neuro, Inc.	ClearPoint CP-WRK-05	2023-12-27
GUDID 00850376007888 Clearpoint Neuro, Inc.	ClearPoint CP-SFW-11-22	2023-12-27
GUDID 00850376007895 CLEARPOINT NEURO, INC.	ClearPoint Array CPA-WRK-02	2023-11-06
GUDID 00850376007871 CLEARPOINT NEURO, INC.	ClearPoint Array CPA-SFW-11-12	2023-11-06
GUDID 00850376007840 CLEARPOINT NEURO, INC.	ClearPoint NGS-TC-01	2023-01-13
GUDID 00850376007857 CLEARPOINT NEURO, INC.	ClearPoint CP-WRK-04	2022-10-14
GUDID 00850376007703 CLEARPOINT NEURO, INC.	ClearPoint CP-SFW-11-21	2022-10-14
GUDID 00850359007966 CLEARPOINT NEURO, INC.	ClearPoint Maestro CPM-SFW-1	2022-10-12
PMN K222519 ClearPoint Neuro, Inc.	ClearPoint System	2022-09-16
GUDID 00850376007659 CLEARPOINT NEURO, INC.	ClearPoint Array CPA-SFW-11-11	2022-05-03
GUDID 00850376007710 CLEARPOINT NEURO, INC.	SMARTFrame Array NGS-SFA-DG-03	2022-04-22
GUDID 00850376007758 CLEARPOINT NEURO, INC.	SmartFrame NGS-SF-04-11	2022-02-08
GUDID 00850376007666 CLEARPOINT NEURO, INC.	ClearPoint NGS-XG-06	2022-02-04
GUDID 00850376007574 CLEARPOINT NEURO, INC.	ClearPoint CP-INHFF-342-01	2021-08-20
GUDID 00850376007000 CLEARPOINT NEURO, INC.	ClearPoint CP-MPHFF-132-01	2021-08-20
GUDID 00850376007635 CLEARPOINT NEURO, INC.	Array CP-NGS-SFA-MRDK	2021-07-22
GUDID 00850376007628 CLEARPOINT NEURO, INC.	Array CP-NGS-SFA-MRBH	2021-07-22
GUDID 00850376007604 CLEARPOINT NEURO, INC.	Array NGS-SFA-03-2	2021-07-22
GUDID 00850376007598 CLEARPOINT NEURO, INC.	SmartFrame Array NGS-SFA-02-2	2021-07-22
GUDID 00850376007512 CLEARPOINT NEURO, INC.	ClearPoint CP-INHFF-132-01	2021-04-26
GUDID 00850376007611 CLEARPOINT NEURO, INC.	Array CP-NGS-SFA-ORMR	2021-04-15
GUDID 00850359007959 CLEARPOINT NEURO, INC.	SmartTip NGS-DB-45-S	2021-04-15
GUDID 00850359007935 CLEARPOINT NEURO, INC.	SmartFrame Array Thumbwheel Extension	2021-04-15
GUDID 00850359007928 CLEARPOINT NEURO, INC.	SmartFrame Array	2021-04-15
GUDID 00850359007911 CLEARPOINT NEURO, INC.	ClearPoint Array Workstation	2021-04-15
GUDID 00850359007904 CLEARPOINT NEURO, INC.	Array NGS-SFA-01-2	2021-04-15
GUDID 00850359007744 CLEARPOINT NEURO, INC.	ClearPoint Array	2021-04-15
GUDID 00850376007581 CLEARPOINT NEURO, INC.	ClearPoint CP-INHFF-242-01	2021-02-22
GUDID 00850376007567 CLEARPOINT NEURO, INC.	ClearPoint CP-INHFF-422-01	2021-02-22
GUDID 00850359007669 CLEARPOINT NEURO, INC.	ClearPoint CP-NGS-11-SKM-XG	2021-02-01
GUDID 00850359007652 CLEARPOINT NEURO, INC.	ClearPoint CP-NGS-11-CG45-XG	2021-02-01
GUDID 00850359007645 CLEARPOINT NEURO, INC.	ClearPoint CP-NGS-11-TP45-XG	2021-02-01
GUDID 00850359007638 CLEARPOINT NEURO, INC.	ClearPoint CP-NGS-11-SCM	2021-02-01
GUDID 00850359007621 CLEARPOINT NEURO, INC.	ClearPoint CP-NGS-11-SKM	2021-02-01
GUDID 00850359007614 CLEARPOINT NEURO, INC.	ClearPoint CP-SFW-11-162	2021-02-01
GUDID 00850359007607 CLEARPOINT NEURO, INC.	ClearPoint CP-SFW-11-20	2021-02-01
GUDID 00850359007591 CLEARPOINT NEURO, INC.	MRI Interventions NGS-HX-M6	2021-02-01
GUDID 00850359007584 CLEARPOINT NEURO, INC.	MRI Interventions NGS-BD-M6	2021-02-01
GUDID 00850359007577 CLEARPOINT NEURO, INC.	ClearPoint CP-EXT-22-01	2021-02-01
GUDID 00850359007560 CLEARPOINT NEURO, INC.	ClearPoint CP-EXT-21-01	2021-02-01
GUDID 00850359007553 CLEARPOINT NEURO, INC.	ClearPoint CP-MON-02	2021-02-01
GUDID 00850359007546 CLEARPOINT NEURO, INC.	ClearPoint CP-WRK-02	2021-02-01
GUDID 00850359007539 CLEARPOINT NEURO, INC.	ClearPoint CP-WRK-03	2021-02-01
GUDID 00850359007508 CLEARPOINT NEURO, INC.	ClearPoint CP-MON-03	2021-02-01
GUDID 00850359007492 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-08	2021-02-01
GUDID 00850359007485 CLEARPOINT NEURO, INC.	Smartflow NGS-NC-07	2021-02-01
GUDID 00850359007478 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-06	2021-02-01
GUDID 00850359007461 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-05	2021-02-01
GUDID 00850359007454 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-04	2021-02-01
GUDID 00850359007447 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-03	2021-02-01
GUDID 00850359007430 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-02	2021-02-01
GUDID 00850359007423 CLEARPOINT NEURO, INC.	SmartFlow NGS-NC-01	2021-02-01
GUDID 00850359007416 CLEARPOINT NEURO, INC.	SmartFrame NGS-RS-03	2021-02-01
GUDID 00850359007409 CLEARPOINT NEURO, INC.	SmartFrame NGS-RS-02	2021-02-01
GUDID 00850359007393 CLEARPOINT NEURO, INC.	SmartFrame NGS-RS-01	2021-02-01
GUDID 00850359007386 CLEARPOINT NEURO, INC.	SmartFrame NGS-CG-01	2021-02-01
GUDID 00850359007379 CLEARPOINT NEURO, INC.	ClearPoint NGS-BM-05	2021-02-01
GUDID 00850359007362 CLEARPOINT NEURO, INC.	SmartTip NGS-DB-45	2021-02-01
GUDID 00850359007355 CLEARPOINT NEURO, INC.	SmartTip NGS-DB-01	2021-02-01
GUDID 00850359007348 CLEARPOINT NEURO, INC.	SmartTwist NGS-HD-01	2021-02-01
GUDID 00850359007331 CLEARPOINT NEURO, INC.	SmartFrame NGS-SK-01-11	2021-02-01
GUDID 00850359007324 CLEARPOINT NEURO, INC.	SmartFrame NGS-SM-01	2021-02-01
GUDID 00850359007317 CLEARPOINT NEURO, INC.	SmartFrame NGS-XG-02	2021-02-01
GUDID 00850359007300 CLEARPOINT NEURO, INC.	SmartFrame NGS-XG-01	2021-02-01
GUDID 00850359007294 CLEARPOINT NEURO, INC.	MRII NGS-EC-16X24-06	2021-02-01
GUDID 00850359007287 CLEARPOINT NEURO, INC.	SmartFrame NGS-GT-06	2021-02-01
GUDID 00850359007270 CLEARPOINT NEURO, INC.	SmartFrame NGS-GT-05	2021-02-01
GUDID 00850359007263 CLEARPOINT NEURO, INC.	SmartFrame NGS-GT-04	2021-02-01
GUDID 00850359007256 CLEARPOINT NEURO, INC.	SmartFrame NGS-GT-03	2021-02-01
GUDID 00850359007249 CLEARPOINT NEURO, INC.	SmartFrame NGS-GT-02	2021-02-01
GUDID 00850359007232 CLEARPOINT NEURO, INC.	SmartFrame NGS-GT-01	2021-02-01
GUDID 00850359007225 CLEARPOINT NEURO, INC.	ClearPoint NGS-PD-05	2021-02-01
GUDID 00850359007218 CLEARPOINT NEURO, INC.	ClearPoint NGS-PD-04	2021-02-01
GUDID 00850359007201 CLEARPOINT NEURO, INC.	ClearPoint NGS-PD-03-L	2021-02-01
GUDID 00850359007195 CLEARPOINT NEURO, INC.	ClearPoint NGS-PD-03	2021-02-01
GUDID 00850359007188 CLEARPOINT NEURO, INC.	ClearPoint NGS-PD-02-L	2021-02-01
GUDID 00850359007171 CLEARPOINT NEURO, INC.	SmartFrame NGS-TE-01	2021-02-01
GUDID 00850359007164 CLEARPOINT NEURO, INC.	SmartFrame NGS-HC-01	2021-02-01
GUDID 00850359007157 CLEARPOINT NEURO, INC.	SmartFrame NGS-AK-01-11	2021-02-01
GUDID 00850359007140 CLEARPOINT NEURO, INC.	SmartGrid NGS-SG-01-11	2021-02-01
GUDID 00850359007133 CLEARPOINT NEURO, INC.	SmartFrame NGS-SF-03-11	2021-02-01
GUDID 00850359007126 CLEARPOINT NEURO, INC.	SmartFrame NGS-SF-02-11	2021-02-01
GUDID 00850359007119 CLEARPOINT NEURO, INC.	SmartFrame NGS-SF-01-11	2021-02-01
GUDID 00850359007102 CLEARPOINT NEURO, INC.	SmartFrame CP-NGS-11-TE-CG45	2021-02-01
GUDID 00850359007096 CLEARPOINT NEURO, INC.	SmartFrame CP-NGS-11-TE-TP45	2021-02-01
GUDID 00850359007089 CLEARPOINT NEURO, INC.	SmartFrame CP-NGS-11-HC-TP45	2021-02-01
GUDID 00850359007072 CLEARPOINT NEURO, INC.	SmartFrame CP-NGS-11-HC-TP32-E	2021-02-01
PMN K202575 ClearPoint Neuro, Inc.	ClearPoint Array System	2021-01-22
PMN K191701 | HBL ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Inflexion Head Frame	2019-12-03
PMN K191400 | HAW ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Voyager Trajectory Guide	2019-12-03
PMN K180854 | HAW ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	V-Tag	2019-03-12
PMN K181731 | GWG ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint Pursuit	2018-12-17
PMN K181195 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System	2018-12-17
PMN K181195 | HAW ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System	2018-12-17
PMN K171257 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Clearpoint System	2017-11-06
PMN K171257 | HAW ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Clearpoint System	2017-11-06
PMN K160434 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Clearpoint System	2016-11-04
PMN K160434 | HAW ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Clearpoint System	2016-11-04
PMN K160129 | HBG ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SmartTwist MRI Hand Drill, SmartTip Drill Bit Kit	2016-11-04
PMN K122456 | HBG ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SmartTwist MRI Hand Drill, SmartTip Drill Bit Kit	2016-11-04
PMN K151536 | HBG ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SmartTwist MRII Hand Drill, SmartTip MRII Drill Bit Kit, 4.5mm, 6.0mm	2015-12-21
PMN K142505 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System	2015-12-21
PMN K142505 | HAW ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System	2015-12-21
PMN K111802 | MOS ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Brain Array Siemens 3T	2011-11-01
PMN K111259 | MOS ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Brain Array GE 1.5T	2011-11-01
PMN K111073 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTGrid	2011-11-01
PMN K111073 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTFrame	2011-11-01
PMN K111073 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System 3T	2011-11-01
PMN K111073 | LNH ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTGrid	2011-11-01
PMN K111073 | LNH ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTFrame	2011-11-01
PMN K111073 | LNH ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System 3T	2011-11-01
PMN K090267 | MOS ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Braine Array Siemens 1.5T	2011-11-01
PMN K102101 | HCD ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SmartFlow	2011-04-28
PMN K100836 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTGrid	2010-07-07
PMN K100836 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTFrame	2010-07-07
PMN K100836 | ORR ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System	2010-07-07
PMN K100836 | LNH ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTGrid	2010-07-07
PMN K100836 | LNH ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	SMARTFrame	2010-07-07
PMN K100836 | LNH ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	ClearPoint System	2010-07-07
PMN K091439 | HBL ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	Head Fixation Arc	2009-11-13
PMN K091343 | KKX ClearPoint Neuro Inc. [ClearPoint Neuro, Inc.]	MRI Neuro Drape	2009-11-13

Related Finance Registrations

CAGE Code	5XXY0	CLEARPOINT NEURO, INC.
S.A.M. Registration	5XXY0 [959181160]	CLEARPOINT NEURO, INC.