Synaptive Medical Inc

FDA Filings

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

FDA Registration(s)
Registration Number3012075008
FEI Number3012075008
NameElaine Duncan
Owner & OperatorSynaptive Medical Inc
Contact Address555 Richmond St West, Suite 800
Toronto CA-ON Ontario M5V 3B1 CA
Official Correspondent
  • Maham Ansari
  • 1-844-4627246-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trl
Houlton, WI 54082 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Synaptive Medical Inc
Modus IR 2024-04-10
Synaptive Medical Inc
Evry 2023-10-24
Synaptive Medical Inc
Modus Plan SYN-08662023-10-18
Synaptive Medical Inc
Modus Blue 2023-03-14
Synaptive Medical Inc
Modus X 2023-03-14
Synaptive Medical Inc
Modus X 2023-03-14
Elaine Duncan [Synaptive Medical Inc]
Modus Nav2019-10-04
Synaptive Medical Inc
BrightMatter Plan SYN-00042019-08-16
Synaptive Medical Inc
BrightMatter Plan SYN-00042019-08-16
Synaptive Medical Inc
BrightMatter Plan SYN-00042019-08-16
Synaptive Medical Inc
Modus Plan SYN-08662019-08-14
Synaptive Medical Inc
BrightMatter Plan SYN-08662019-08-07
Synaptive Medical Inc.
Modus Nav2019-07-14
Synaptive Medical Inc
ClearCanvas Personal Edition Workstation SYN-05242019-05-23
Synaptive Medical Inc
ImageDrive Pro SYN-06272019-05-23
Synaptive Medical Inc
ImageDrive Clinical SYN-05782019-05-23
Synaptive Medical Inc
BrightMatter Guide Software SYN-00272018-10-29
Synaptive Medical Inc
BrightMatter Guide Software SYN-00272018-07-06
Synaptive Medical Inc
BrightMatter Pointer Sterilizable Storage Tray 2018-07-06
Synaptive Medical Inc
BrightMatter Pointer 2018-07-06
Synaptive Medical Inc
BrightMatter Guide Software SYN-00272018-07-06
Synaptive Medical Inc
BrightMatter Guide 2018-07-06
Synaptive Medical Inc
BrightMatter Guide Sterilizable Storage Tray 2018-07-06
Synaptive Medical Inc
BrightMatter Patient Reference 2018-07-06
Synaptive Medical Inc
Tracking Array for Brainpath 2018-07-06
Synaptive Medical Inc
BrightMatter Guide Calibration Block 2018-07-06
Synaptive Medical Inc
Pointer Tool (SS) 2018-07-06
Synaptive Medical Inc
Trackable Suction - Tube 10-M-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 8-M-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 6-M-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 4-M-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 10-S-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 8-S-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 6-S-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 4-S-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 12-L-90 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 10-L-90 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 6-L-90 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 12-L-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 6-L-30 2018-04-03
Synaptive Medical Inc
Trackable Suction - Suction Set Malleable 2018-04-03
Synaptive Medical Inc
Trackable Suction - Tube 10-L-30 2018-04-03
Synaptive Medical Inc
Synaptive Trackable Suction - Standard Suction Set 2018-04-03
Synaptive Medical Inc
Trackable Suction - Suction Handle 2018-04-03
Synaptive Medical Inc
Trackable Suction - Sterilizable Storage Tray 2018-04-03
Elaine Duncan [Synaptive Medical Inc]
Modus Plan2018-03-16
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Plan 1.62018-03-16
Synaptive Medical Inc.
BrightMatter Plan 1.6.02018-03-09
Elaine Duncan [Synaptive Medical Inc]
Fiducial Markers2017-09-27
Elaine Duncan [Synaptive Medical Inc]
Sony LMD-X550MT 4K 3D/2D Surgical Monitor2017-06-14
Elaine Duncan [Synaptive Medical Inc]
Sony LMD-X550MD 4K Surgical Monitor2017-06-14
Elaine Duncan [Synaptive Medical Inc]
Anisotropic Diffusion Phantom2017-01-06
Elaine Duncan [Synaptive Medical Inc]
Synaptive Trackable Suction2016-10-21
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Pointer with BrightMatter Guide2016-08-22
Elaine Duncan [Synaptive Medical Inc]
Barco MDSC-82322016-08-22
Elaine Duncan [Synaptive Medical Inc]
ImageDrive Clinical2016-07-04
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Guide with SurfaceTrace2016-07-04
SYNAPTIVE MEDICAL INC.
BrightMatter Guide With BrightMatter Pointer2016-06-24
SYNAPTIVE MEDICAL INC.
BrightMatter Guide With Surface Trace Registration2016-03-30
SYNAPTIVE MEDICAL INC.
Synaptive ImageDrive Pro2016-03-29
Elaine Duncan [Synaptive Medical Inc]
Patch drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Monitor drape sheet2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Floating estop drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Drive skirt drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Cranial reference drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
Arm drape2015-09-11
Elaine Duncan [Synaptive Medical Inc]
3D Arm drape2015-09-11
SYNAPTIVE MEDICAL INC.
BRIGHTMATTER NAVIGATION SYSTEM2015-04-02
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Navigation System2015-04-02
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Guide2015-04-02
Elaine Duncan [Synaptive Medical Inc]
NDI Passive Spheres2015-04-02
Elaine Duncan [Synaptive Medical Inc]
Modus V2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Vision2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Pointer with Modus V2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Pointer with BrightMatter Drive2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Drive2014-10-20
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Planning2014-06-10
Elaine Duncan [Synaptive Medical Inc]
BrightMatter Plan 1.02014-06-10
SYNAPTIVE MEDICAL INC.
BRIGHTMATTER PLANNING SOFTWARE2014-06-02
Elaine Duncan [Synaptive Medical Inc]
ClearCanvas RIS/PACS2014-05-15

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