This page includes the latest FDA filings for Ninepoint Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008805841 |
| FEI Number | 3008805841 |
| Name | NINEPOINT MEDICAL, INC. |
| Owner & Operator | NinePoint Medical |
| Contact Address | 12 Oak Park Bedford MA 01730 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 12 Oak Park Dr Bedford, MA 01730 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| NINEPOINT MEDICAL, INC. | NvisionVLE Inflation Kit 96101-60 | 2020-05-06 |
NINEPOINT MEDICAL, INC. [NinePoint Medical] | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2019-12-05 |
NINEPOINT MEDICAL, INC. [NinePoint Medical] | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2019-12-05 |
NinePoint Medical, Inc | NvisionVLE Low-profile Optical Probe | 2019-07-19 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Console with IRIS, Upgraded, Refurbished | 2018-12-10 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Console with IRIS, Upgraded | 2018-12-10 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Console with IRIS, Refurbished 94301-MI-R | 2018-12-10 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Console with IRIS 94301-MI | 2018-12-10 |
NINEPOINT MEDICAL, INC. [NinePoint Medical] | NvisionVLE Imaging System | 2018-11-08 |
NinePoint Medical, Inc. | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | 2018-11-02 |
NinePoint Medical, Inc. | NvisionVLE Imaging System, NvisionVLE Optical Probe | 2018-10-16 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Upgrade Refurbished 94301-M-UPG-R | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging System with Targeted Biopsy - Upgrade 94301-M-UPG | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Low Profile Imaging Probe, 20mm Working Distance 95501-20 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Low Profile Imaging Probe, 14mm Working Distance 95501-14 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Low Profile Imaging Probe, 0mm Working Distance 95501-LP | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Probe 14mm Clinical 95101-14C | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Probe 20mm Clinical 95101-20C | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Probe 17mm Clinical 95101-17C | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Probe 14mm Clinical 95301-M-14C | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Probe 20mm Clinical 95301-M-20C | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Probe 17mm Clinical 95301-M-17C | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Console Refurbished 94301-M-R | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Console 94301-M | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Console Refurbished 94101-R | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Console 94101 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Probe 20mm 95301-M-20 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Probe 17mm 95301-M-17 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Marking Probe 14mm 95301-M-14 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Probe 20mm 95101-20 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Probe 17mm 95101-17 | 2018-07-06 |
| NINEPOINT MEDICAL, INC. | NvisionVLE Imaging Probe 14mm 95101-14 | 2018-07-06 |
NINEPOINT MEDICAL, INC. [NinePoint Medical] | NvisionVLE Imaging System with Real Time Targeting | 2016-04-20 |
NINEPOINT MEDICAL, INC | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm Balloon, NvisionVLE Marking Probe, 17mm Balloon,NvisionVLE Marking Probe, 14mm Balloon, NvisionVLE Inflation System | 2016-02-16 |
NINEPOINT MEDICAL, INC. [NinePoint Medical] | NvisionVLE Imaging System | 2015-04-15 |
NINEPOINT MEDICAL, INC. | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory | 2015-02-06 |
NINEPOINT MEDICAL, INC. | NVISION VLE IMAGING SYSTEM | 2013-04-25 |
NINEPOINT MEDICAL, INC | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER | 2012-07-25 |
NINEPOINT MEDICAL, INC | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER | 2011-12-16 |
| NCAGE Code | 5XF12 | NINEPOINT MEDICAL, INC. |
| CAGE Code | 5XF12 | NINEPOINT MEDICAL, INC. |
| S.A.M. Registration | 5XF12 [961880999] | NINEPOINT MEDICAL, INC. |
| DUNS | 961880999 | Ninepoint Medical, Inc. |
| SEC | 0001473959 | NinePoint Medical, Inc. of DELAWARE |