Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

FDA 510(k) Medical Device Manufacturers - Canada

Canadian medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

Compare manufacturers by FDA 510(k) submission activity

Identify clearance rates, active panels and years of FDA activity

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Canada Manufacturers

1–50 of 152

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Orthosoft Inc. (d/b/a) Zimmer CAS Montreal	12	100%	OR RA	CA
2	Bodycad Laboratories, Inc. Quebec City	12	100%	OR	CA
3	Baylis Medical Company, Inc. Mississauga, Ontario	9	100%	CV	CA
4	Clarius Mobile Health Corp. Vancouver	8	100%	RA	CA
5	Orthosoft D/B/A Zimmer Cas Montreal	7	100%	OR RA	CA
6	Circle Cardiovascular Imaging, Inc. Calgary, Alberta	6	100%	RA	CA
7	Primed Medical Products, Inc. Edmonton, Alberta	5	100%	HO	CA
8	Molli Surgical, Inc. Toronto	5	100%	SU	CA
9	Baylis Medical Technologies, Inc. Mississauga	5	100%	CV SU	CA
10	Opsens, Inc. Quebec	4	100%	CV	CA
11	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Oakville	4	100%	EN NE OP	CA
12	MY01, Inc. Montreal	4	100%	OR	CA
13	Flosonics Medical Toronto	4	100%	CV	CA
14	Sparrow Acoustics, Inc. Lucasville	4	100%	CV	CA
15	Inbella Medical, Inc. Richmond Hill	4	100%	SU	CA
16	Adaptiiv Medical Technologies, Inc. Halifax	3	100%	RA	CA
17	Precision Biologic, Inc. Dartmouth, N.S.	3	100%	HE	CA
18	Luminex Molecular Diagnostics, Inc. Toronto, Ontario	3	100%	MI TX	CA
19	Moleculight, Inc. Toronto	3	100%	SU	CA
20	Profound Medical, Inc. Mississauga	3	100%	GU	CA
21	Luvo Medical Technologies, Inc. Cambridge	3	100%	SU	CA
22	Sonic Incytes Vancouver	3	100%	RA	CA
23	Canadian Pioneer Medical Technology Corporation Vaughan	3	100%	SU	CA
24	Kane Biotech, Inc. Winnipeg	3	100%	SU	CA
25	Casebioscience, Inc. Guelph	2	100%	OB	CA
26	Pega Medical, Inc. Quebec	2	100%	OR	CA
27	Innovative Bioceramix, Inc. Vancouver, Bc	2	100%	DE	CA
28	Scican , Ltd. Toronto	2	100%	HO	CA
29	DNA Genotek, Inc. Ottawa Ontario	2	50%	CH MI	CA
30	Kent Imaging, Inc. Calgary	2	100%	SU	CA
31	Tone-A-Matic International, Inc. Mississauga, Ontario	2	100%	NE	CA
32	Synaptive Medical, Inc. Toronto On	2	100%	NE RA	CA
33	Trudell Medical International London	2	100%	AN	CA
34	Claronav, Inc. Toronto	2	100%	DE	CA
35	7D Surgical, Inc. Toronto	2	100%	OR	CA
36	Myndtec, Inc. Mississauga	2	100%	PM	CA
37	Medxl, Inc. Pointe-Claire	2	100%	HO	CA
38	Change Healthcare Canada Company Richmond	2	100%	RA	CA
39	Verathon Medical (Canada) Ulc Burnaby	2	100%	EN	CA
40	Healstone Biotech, Inc. Vancouver	2	100%	CH TX	CA
41	Limbus Ai, Inc. Regina	2	100%	RA	CA
42	Soundbite Medical Solutions, Inc. Montreal	2	100%	CV	CA
43	Abk Biomedical, Inc. Halifax	2	100%	CV	CA
44	Denti.Ai Technology, Inc. Toronto	2	100%	RA	CA
45	Canadian Pioneer Medical Technology Corporation (Cpmt Laser) Vaughan	2	100%	SU	CA
46	Imeka Solutions, Inc. Sherbrooke	2	100%	RA	CA
47	Supermax Healthcare Canada-Supermax Medical Saint-Bruno-De-Montarville	2	100%	HO	CA
48	Optina Diagnostics, Inc. Montreal	2	100%	OP	CA
49	Cpmt Laser (Canadian Pioneer Medical Technology Corporation) Toronto	2	100%	PM SU	CA
50	Circle Cardiovascular Imaging Calgary	2	100%	RA	CA

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.