FDA device clearances in Canada: 100 since Nov 2024

Name: FDA device clearances for applicants in Canada
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in Canada: 100 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 4 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/country/canada, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 23, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 100 device decisions for applicants in Canada from November 12, 2024 to October 23, 2026: 100 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 70 applicants. The newest, K261679 on October 23, 2026, is BlineSlide from Deep Breathe, Inc..

The request: Every new FDA device clearance or approval for a company in Canada, with its address, the device and the product code. $10 of credit on sign-up, no card.

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SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

100Decisions
100510(k) and De Novo
0PMA
October 23, 2026Latest decision

Newest decisions

The newest 100 of 100, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 23, 2026	K261679	BlineSlide	Deep Breathe, Inc.	Canada	Substantially Equivalent	510(k) traditional	POK	accessdata.fda.gov
October 19, 2026	K260403	7D Surgical System (10-0001)	7D Surgical ULC	Canada	Substantially Equivalent	510(k) traditional	OLO	accessdata.fda.gov
September 30, 2026	K262621	Rapid Barostat Bag (RBB) Pump and Catheter System	Mui Scientific, Inc.	Canada	Substantially Equivalent	510(k) special	FFX	accessdata.fda.gov
September 23, 2026	K261874	Syneris PACS v.1.0.1.0	Syneris	Canada	Substantially Equivalent	510(k) traditional	LLZ	accessdata.fda.gov
September 18, 2026	K261736	MAGENTA BLAST	Future Fertility, Inc.	Canada	Substantially Equivalent	510(k) traditional	PBH	accessdata.fda.gov
September 16, 2026	K261913	X°Port Heart Preservation System	Traferox Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	MSB	accessdata.fda.gov
September 11, 2026	K262007	PRIMED AAMI Level 3 Open Back Gowns	PRIMED Medical Products, Inc.	Canada	Substantially Equivalent	510(k) traditional	QPC	accessdata.fda.gov
September 9, 2026	K260652	ColActive Plus	Covalon Technologies, Ltd.	Canada	Substantially Equivalent	510(k) traditional	KGN	accessdata.fda.gov
September 2, 2026	K254198	Trexo Theo	Trexo Robotics, Inc.	Canada	Substantially Equivalent	510(k) traditional	PHL	accessdata.fda.gov
September 1, 2026	K261811	PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple...	PRIMED Medical Products, Inc.	Canada	Substantially Equivalent	510(k) traditional	QSO	accessdata.fda.gov
August 20, 2026	K253807	Valence InVent Xtend (CVG-4101-VXA)	Convergence Medical Sciences , Ltd.	Canada	Substantially Equivalent	510(k) traditional	MOD	accessdata.fda.gov
August 13, 2026	K260413	Levo Gen 2 Tinnitus Therapy System	Levo Medical Corporation	Canada	Substantially Equivalent	510(k) traditional	KLW	accessdata.fda.gov
July 23, 2026	K251576	Total Flow Medical Femoral Arterial (TFA) cannula	Total Flow Medical Limited	Canada	Substantially Equivalent	510(k) traditional	SFF	accessdata.fda.gov
July 21, 2026	K260500	ResolutionMD	ResolutionMD, Inc.	Canada	Substantially Equivalent	510(k) traditional	LLZ	accessdata.fda.gov
July 17, 2026	K253963	Cubresa BrainPET	Cubresa, Inc.	Canada	Substantially Equivalent	510(k) traditional	OUO	accessdata.fda.gov
June 12, 2026	K253015	Cognitive Function Neuroimaging (cfNI) Software (1.0.0)	VoxNeuro, Inc.	Canada	Substantially Equivalent	510(k) traditional	OLU	accessdata.fda.gov
June 11, 2026	K253650	Anura Mobile Core SDK (M1)	Nuralogix Corporation	Canada	Substantially Equivalent	510(k) traditional	QME	accessdata.fda.gov
June 10, 2026	K254121	Colli-PeeDx Urine Collection Kit	DNA Genotek, Inc.	Canada	Substantially Equivalent	510(k) traditional	SIH	accessdata.fda.gov
June 9, 2026	K252914	Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)	Hathor Professional Skincare , Ltd.	Canada	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
June 4, 2026	K261510	Signature ONE System	Orthosoft Inc. (d/b/a) Zimmer CAS	Canada	Substantially Equivalent	510(k) special	QHE	accessdata.fda.gov
June 1, 2026	K260456	VI°Port Liver Preservation System	Traferox Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	KDN	accessdata.fda.gov
May 28, 2026	K261405	ANDI 2.2	Imeka Solutions, Inc.	Canada	Substantially Equivalent	510(k) special	QIH	accessdata.fda.gov
May 28, 2026	K260295	Helio Kids; Apex P	Motion Composites	Canada	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
May 21, 2026	K260582	ROSA® Shoulder System	Orthosoft Inc. (d/b/a) Zimmer CAS	Canada	Substantially Equivalent	510(k) traditional	OLO	accessdata.fda.gov
May 11, 2026	K253696	CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456)...	Verathon Medical (Canada) Ulc	Canada	Substantially Equivalent	510(k) traditional	FAJ	accessdata.fda.gov
April 24, 2026	K252810	FloPatch FP120	Flosonics Medical	Canada	Substantially Equivalent	510(k) special	DPW	accessdata.fda.gov
April 17, 2026	K252945	Novasight Hybrid System	Conavi Medical, Inc.	Canada	Substantially Equivalent	510(k) traditional	OBJ	accessdata.fda.gov
March 30, 2026	K254207	AiORTA - Plan v2.0	ViTAA Medical Solutions, Inc.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
March 16, 2026	K253944	Data Analysis Facilitation Suite (DAFS)	Voronoi Health Analytics Incorporated	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
March 2, 2026	K253593	Clarius Ejection Fraction AI	Clarius Mobile Health Corp.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
February 27, 2026	K253536	Evala Nerve Stimulator (EPNR002)	Epineuron Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	ETN	accessdata.fda.gov
February 24, 2026	K251678	Swift Ray 1	Swift Medical, Inc.	Canada	Substantially Equivalent	510(k) traditional	QJF	accessdata.fda.gov
February 20, 2026	K252672	CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)	Casebioscience, Inc.	Canada	Substantially Equivalent	510(k) traditional	MQL	accessdata.fda.gov
February 19, 2026	K260308	TrueFit Bolus	Adaptiiv Medical Technologies, Inc.	Canada	Substantially Equivalent	510(k) special	MUJ	accessdata.fda.gov
February 4, 2026	K260104	Signature ONE System	Orthosoft Inc. (d/b/a) Zimmer CAS	Canada	Substantially Equivalent	510(k) special	QHE	accessdata.fda.gov
January 29, 2026	K253611	Falco Fusion System	Mcnicoll Surgical, Inc.	Canada	Substantially Equivalent	510(k) traditional	OUR	accessdata.fda.gov
January 28, 2026	K253842	Vena MicroAngioscope System	Vena Medical Holdings Corp	Canada	Substantially Equivalent	510(k) traditional	LYK	accessdata.fda.gov
January 27, 2026	K251435	InbellaIgnite RF System	Inbella Medical, Inc.	Canada	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
January 18, 2026	K254114	Baylis Connector Cable	Baylis Medical Technologies, Inc.	Canada	Substantially Equivalent	510(k) special	DSA	accessdata.fda.gov
January 16, 2026	K251900	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Canada	Substantially Equivalent	510(k) traditional	LXC	accessdata.fda.gov
January 16, 2026	K251367	OptoMonitor 3	Opsens, Inc.	Canada	Substantially Equivalent	510(k) traditional	DXO	accessdata.fda.gov
January 8, 2026	K252759	revyve® Antimicrobial Skin and Wound Cleanser	Kane Biotech, Inc.	Canada	Substantially Equivalent	510(k) traditional	FRO	accessdata.fda.gov
November 25, 2025	K250694	Scaida BrainCT-ICH (v1.0)	Mlhealth 360	Canada	Substantially Equivalent	510(k) traditional	QAS	accessdata.fda.gov
November 18, 2025	K243981	Hexoskin Medical System (7100-00016)	Carre Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	DXH	accessdata.fda.gov
November 13, 2025	K251314	Rosa® Knee System	Orthosoft Inc. (d/b/a) Zimmer CAS	Canada	Substantially Equivalent	510(k) traditional	OLO	accessdata.fda.gov
November 4, 2025	K252964	PRIMED Surgical and Procedure Masks	Primed Medical Products, Inc.	Canada	Substantially Equivalent	510(k) traditional	FXX	accessdata.fda.gov
October 30, 2025	K250337	AiORTA - Plan	ViTAA Medical Solutions, Inc.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
October 28, 2025	K253300	Fine Osteotomy	Bodycad Laboratories, Inc.	Canada	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 28, 2025	K250275	PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch	Baylis Medical Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
October 27, 2025	K251027	cvi42 Coronary Plaque Software Application	Circle Cardiovascular Imaging, Inc.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
October 22, 2025	K252298	ANDI 2.0	Imeka Solutions, Inc.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
October 21, 2025	K250394	Fine TTO	Bodycad Laboratories, Inc.	Canada	Substantially Equivalent	510(k) traditional	PBF	accessdata.fda.gov
October 15, 2025	K252367	InbellaMulti System	Inbella Medical, Inc.	Canada	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
October 14, 2025	K252637	Community Containers (Flap and Daisy)	Keter Canada, Inc.	Canada	Substantially Equivalent	510(k) traditional	MMK	accessdata.fda.gov
October 6, 2025	K252007	BlineSlide	Deep Breathe, Inc.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
October 3, 2025	K243968	Revolve Surgical System	Revolve Surgical, Inc.	Canada	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
October 1, 2025	K251767	Vena MicroAngioscope System	Vena Medical Holdings Corp	Canada	Substantially Equivalent	510(k) traditional	LYK	accessdata.fda.gov
September 17, 2025	K251902	Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)	Vitacore Industries, Inc.	Canada	Substantially Equivalent	510(k) traditional	FXX	accessdata.fda.gov
September 15, 2025	K252128	Zener® (model ZEN-001-B1)	Uvx, Inc.	Canada	Substantially Equivalent	510(k) traditional	FRA	accessdata.fda.gov
September 12, 2025	K252595	Stethophone Pro	Sparrow Acoustics, Inc.	Canada	Substantially Equivalent	510(k) special	DQD	accessdata.fda.gov
September 11, 2025	K251158	PowerWire® 14 Radiofrequency Guidewire Kit	Baylis Medical Technologies, Inc.	Canada	Unknown	510(k) traditional	PDU	accessdata.fda.gov
September 4, 2025	K250770	Optina-4C (MHRC-C1N)	Optina Diagnostics, Inc.	Canada	Substantially Equivalent	510(k) traditional	HKI	accessdata.fda.gov
August 29, 2025	K250003	GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)	Geneseeq Technology, Inc.	Canada	Substantially Equivalent	510(k) traditional	PZM	accessdata.fda.gov
August 25, 2025	K251440	CRYOcheck Chromogenic Factor VIII	Precision Biologic, Inc.	Canada	Substantially Equivalent	510(k) traditional	GGP	accessdata.fda.gov
August 21, 2025	K250923	Fine Osteotomy	Bodycad Laboratories, Inc.	Canada	Substantially Equivalent	510(k) traditional	HRS	accessdata.fda.gov
August 21, 2025	K243965	Origin	Nerv Technology Inc. (D.B.A.) Fluidai Medical	Canada	Substantially Equivalent	510(k) traditional	SFO	accessdata.fda.gov
July 25, 2025	K252215	InbellaMAX System	Inbella Medical , Ltd.	Canada	Substantially Equivalent	510(k) special	GEI	accessdata.fda.gov
July 1, 2025	K250221	StrokeSENS ASPECTS Software Application	Circle Cardiovascular Imaging, Inc.	Canada	Substantially Equivalent	510(k) traditional	POK	accessdata.fda.gov
June 26, 2025	K251728	Velacur One (LI-1100)	Sonic Incytes Medical Corp	Canada	Substantially Equivalent	510(k) special	IYO	accessdata.fda.gov
June 25, 2025	K250747	Globe® Pulsed Field System	Kardium, Inc.	Canada	Substantially Equivalent	510(k) traditional	DQK	accessdata.fda.gov
June 20, 2025	K251114	FloPatch FP120	Flosonics Medical	Canada	Substantially Equivalent	510(k) traditional	DPW	accessdata.fda.gov
June 20, 2025	K243053	Navient Image Guided Navigation System (ENT) (955-NC-NC)	Claronav	Canada	Substantially Equivalent	510(k) traditional	PGW	accessdata.fda.gov
June 6, 2025	K250321	GCI Sterilization Wrappers	George Courey, Inc.	Canada	Substantially Equivalent	510(k) traditional	FRG	accessdata.fda.gov
June 3, 2025	K250529	Globe Introducer (601-01001)	Kardium, Inc.	Canada	Substantially Equivalent	510(k) traditional	DRA	accessdata.fda.gov
May 29, 2025	K251325	VersaCross Connect Transseptal Dilator	Baylis Medical Company, Inc.	Canada	Substantially Equivalent	510(k) special	DRE	accessdata.fda.gov
May 8, 2025	K250226	Clarius Median Nerve AI	Clarius Mobile Health Corp.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
May 2, 2025	K250629	Sutil Rich Personal Lubricant	Hathor Professional Skincare , Ltd.	Canada	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
May 1, 2025	K243870	X°Port Lung Preservation System; X°Port Lung Preservation Solution	Traferox Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	KDN	accessdata.fda.gov
April 16, 2025	K243853	Clarius Prostate AI	Clarius Mobile Health Corp.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
April 4, 2025	K241982	DeepFoqus (DeepFoqus-Accelerate)	Foqus Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
March 26, 2025	K242669	SnapshotGLO (KB100)	Kent Imaging, Inc.	Canada	Substantially Equivalent	510(k) traditional	QJF	accessdata.fda.gov
March 21, 2025	K242107	CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES...	Casebioscience, Inc.	Canada	Substantially Equivalent	510(k) traditional	MQL	accessdata.fda.gov
March 13, 2025	K242997	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Canada	Substantially Equivalent	510(k) traditional	LXC	accessdata.fda.gov
February 26, 2025	K241222	Ventripoint Medical System Plus (VMS+) 4.0	Ventripoint Diagnostics , Ltd.	Canada	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
February 25, 2025	K241601	EMS (FlexPulse, MagnaCore, Magnetika)	Cpmt Laser (Canadian Pioneer Medical Technology Corporation)	Canada	Substantially Equivalent	510(k) traditional	NGX	accessdata.fda.gov
February 21, 2025	K241983	Fassier-Duval Telescoping IM System	Orthopediatrics Canada Ulc Dba Pega Medical	Canada	Substantially Equivalent	510(k) traditional	HSB	accessdata.fda.gov
February 12, 2025	K241418	OptoMonitor 3	Opsens, Inc.	Canada	Substantially Equivalent	510(k) traditional	DXO	accessdata.fda.gov
February 11, 2025	K250200	InbellaBody System	Inbella Medical, Inc.	Canada	Substantially Equivalent	510(k) special	GEI	accessdata.fda.gov
February 5, 2025	K241327	Navient Image Guide Navigation System (955-NC-NC), Cranial	Claronav	Canada	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
January 21, 2025	K241443	Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models...	Hathor Professional Skincare , Ltd.	Canada	Substantially Equivalent	510(k) traditional	NUC	accessdata.fda.gov
January 15, 2025	K242667	AeroChamber2go Anti-Static Valved Holding Chamber	Trudell Medical International	Canada	Substantially Equivalent	510(k) traditional	NVP	accessdata.fda.gov
January 10, 2025	K243111	Bowhead ERA Wheelchairs	Bowhead Design Corp.	Canada	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
January 3, 2025	K243737	Inbella RF System	Inbella Medical, Inc.	Canada	Substantially Equivalent	510(k) traditional	GEI	accessdata.fda.gov
December 27, 2024	K242480	FLASH EVD System (10-0002)	7D Surgical ULC	Canada	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
December 19, 2024	K242954	Integrity V500 (Integrity, Integrity with VEMP)	Vivosonic, Inc.	Canada	Substantially Equivalent	510(k) traditional	GWJ	accessdata.fda.gov
December 17, 2024	K240798	Cntrl+ Bladder Support Pessary	Cntrl+, Inc.	Canada	Substantially Equivalent	510(k) traditional	HHW	accessdata.fda.gov
November 26, 2024	K240650	LungProtect	Traferox Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	KDN	accessdata.fda.gov
November 19, 2024	K242930	Natus BrainWatch System	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)	Canada	Substantially Equivalent	510(k) traditional	OMC	accessdata.fda.gov
November 12, 2024	K242502	Aurelia Surgical Mask ASTM Level-3 (2130)	Supermax Healthcare Canada Supermax Medical	Canada	Substantially Equivalent	510(k) traditional	FXX	accessdata.fda.gov
November 12, 2024	K241981	Change Healthcare Stratus Imaging PACS	Change Healthcare Canada Company	Canada	Substantially Equivalent	510(k) traditional	LLZ	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Traferox Technologies, Inc.	4	September 16, 2026
Orthosoft Inc. (d/b/a) Zimmer CAS	4	June 4, 2026
Inbella Medical, Inc.	4	January 27, 2026
Hathor Professional Skincare , Ltd.	3	June 9, 2026
Clarius Mobile Health Corp.	3	March 2, 2026
Baylis Medical Technologies, Inc.	3	January 18, 2026
Bodycad Laboratories, Inc.	3	October 28, 2025
Deep Breathe, Inc.	2	October 23, 2026
7D Surgical ULC	2	October 19, 2026
PRIMED Medical Products, Inc.	2	September 11, 2026
Imeka Solutions, Inc.	2	May 28, 2026
Flosonics Medical	2	April 24, 2026
ViTAA Medical Solutions, Inc.	2	March 30, 2026
Casebioscience, Inc.	2	February 20, 2026
Vena Medical Holdings Corp	2	January 28, 2026
MY01, Inc.	2	January 16, 2026
Opsens, Inc.	2	January 16, 2026
Circle Cardiovascular Imaging, Inc.	2	October 27, 2025
Kardium, Inc.	2	June 25, 2025
Claronav	2	June 20, 2025

By panel

Panel	Decisions	Latest
Radiology	21	October 23, 2026
Cardiovascular	14	July 23, 2026
General, Plastic Surgery	13	September 11, 2026
Neurology	9	October 19, 2026
Gastroenterology, Urology	9	September 30, 2026
Obstetrics/Gynecology	7	September 18, 2026
Orthopedic	7	June 4, 2026
Unknown	4	September 9, 2026
Physical Medicine	4	September 2, 2026
General Hospital	3	October 14, 2025
Anesthesiology	2	August 20, 2026
Ear, Nose, Throat	2	August 13, 2026
Microbiology	1	June 10, 2026
Ophthalmic	1	September 4, 2025
Pathology	1	August 29, 2025
Hematology	1	August 25, 2025
Clinical Chemistry	1	August 21, 2025

By decision type

Decision type	Decisions	Latest
510(k) traditional	87	October 23, 2026
510(k) special	13	September 30, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.