Is this your brand? Sign in to claim ownership.

Synaptive Medical Inc

Canada·CA-MF-000010705

Last updated September 17, 2026

Information

Country: Canada
Address: 5055, Satellite Drive, Mississauga, Ontario, Canada
Website: www.synaptivemedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Michael McDonald
EUDAMED SRN: CA-MF-000010705
FDA FEI Number: 3012075008
DUNS Number: —

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
Syn Tube 6-L-90 Suction Instrument	SYN-0654	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 12-L-90 Suction Instrument	SYN-0656	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 10 S 30 Suction Instrument	SYN-0674	EUDAMEDFDA UDI	Class IIa	Active
Suction Sterilizable Storage Tray	SYN-0618	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 10-L-30 Suction Instrument	SYN-0652	EUDAMEDFDA UDI	Class IIa	Active
Brightmatter Navigation System	K142024	FDA 510(k)	Class II	Active
Synaptive ImageDrive Pro	K153284	FDA 510(k)	Class II	Active
Modus IR	K231986	FDA 510(k)	Class II	Active
BrightMatter Plan 1.6.0	K180394	FDA 510(k)	Class II	Active
Brightmatter Planning Software	K140337	FDA 510(k)	Class II	Active
BrightMatter Guide with Surface Trace Registration	K153281	FDA 510(k)	Class II	Active
Evry	K200327	FDA 510(k)	Class II	Active
Synq Software Version 1.3	K232981	FDA 510(k)	Class II	Active
BrightMatter Guide with BrightMatter Pointer	K160523	FDA 510(k)	Class II	Active
Modus Nav	K183325	FDA 510(k)	Class II	Active
Syn Tube 8 M 30 Suction Instrument	SYN-0677	EUDAMEDFDA UDI	Class IIa	Active
Synaptive Long Pointer	SYN-0975	EUDAMEDFDA UDI	Class I	Active
Syn Tube 6 M 30 Suction Instrument	SYN-0676	EUDAMEDFDA UDI	Class IIa	Active
Modus V	SYN-0903	EUDAMEDFDA UDI	Class I	Active
Calibration Block	SYN-0014	EUDAMEDFDA UDI	Class I	Active
Brightmatter Sterilizable Storage Tray	SYN-0596	EUDAMEDFDA UDI	Class I	Active
Modus Blue	SYN-0988	EUDAMEDFDA UDI	Class I	Active
Syn Tube 8 S 30 Suction Instrument	SYN-0673	EUDAMEDFDA UDI	Class IIa	Active
Modus Plan	SYN-0866	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 6-L-30 Suction Instrument	SYN-0651	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 4 S 30 Suction Instrument	SYN-0671	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 10-L-90 Suction Instrument	SYN-0655	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 4 M 30 Suction Instrument	SYN-0675	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 10 M 30 Suction Instrument	SYN-0678	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 12-L-30 Suction Instrument	SYN-0653	EUDAMEDFDA UDI	Class IIa	Active
Suction Set Malleable	SYN-0783	EUDAMEDFDA UDI	Class IIa	Active
Modus X	SYN-0976	EUDAMEDFDA UDI	Class I	Active
Pointer Set Sterilizable Storage Tray	SYN-0754	EUDAMEDFDA UDI	Class I	Active
Calibration Device	SYN-0755	EUDAMEDFDA UDI	Class I	Active
Trackable Suction	SYN-0657	EUDAMEDFDA UDI	Class IIa	Active
Syn Tube 6 S 30 Suction Instrument	SYN-0672	EUDAMEDFDA UDI	Class IIa	Active
Reusable Pointer Instruments	SYN-0642	EUDAMEDFDA UDI	Class I	Active
Modus Yellow	SYN-0989	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 23, 2021	Z-1955-2021	—	terminated	Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Feb 26, 2020	Z-1759-2020	—	terminated	A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Feb 26, 2020	Z-1758-2020	—	terminated	A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Oct 9, 2018	Z-0470-2019	—	terminated	This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
Dec 4, 2015	Z-0480-2016	—	terminated	Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Synaptive Medical Inc US