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.

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Identify clearance rates, active panels and years of FDA activity

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Canada FDA 510(k) Overview

207

Manufacturers

712

Submissions

98%

Clearance rate

Leading Canada FDA 510(k) manufacturers include Diagnostic Chemicals , Ltd., Excel Tech. , Ltd., Synermed, Inc. and 205 others.

Canadian medical device manufacturers have submitted 712 FDA 510(k) notifications since 1985, with a 97.6% clearance rate. Canada's medtech sector is well-integrated with the U.S. regulatory pathway, with 207 manufacturers covering a broad range of specialties including neurology, cardiovascular and general hospital devices.

Active in FDA 510(k) submissions since 1985. Many Canada manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Canada Manufacturers

1–50 of 208

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Diagnostic Chemicals , Ltd. Charlottetown, P.E.I.	66	100%	CH TX	CA
2	Excel Tech. , Ltd. Oakville,Ontario	58	91%	EN NE PM +1	CA
3	Synermed, Inc. Quebec, Canada	45	100%	CH	CA
4	I.A.F. Production, Inc. Quebec, Canada H7n4z9	29	100%	MI	CA
5	Baylis Medical Co., Inc. Mississauga	28	100%	CV HO IM +3	CA
6	Vas-Cath, Inc. Mississauga, Ontario	27	100%	CV GU HO	CA
7	Luminex Molecular Diagnostics, Inc. Toronto, Ontario	26	92%	CH MG MI +2	CA
8	Baylis Medical Company, Inc. Mississauga, Ontario	24	100%	CV NE OR +1	CA
9	Orthosoft Inc. (d/b/a) Zimmer CAS Montreal	19	100%	OR RA	CA
10	Bodycad Laboratories, Inc. Quebec City	15	100%	OR	CA
11	Clarius Mobile Health Corp. Vancouver	10	100%	RA	CA
12	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Oakville	9	100%	EN NE OP	CA
13	Opsens, Inc. Quebec	8	100%	CV	CA
14	Trudell Medical International London	8	100%	AN	CA
15	7D Surgical, Inc. Toronto	8	100%	NE OR	CA
16	Orthosoft D/B/A Zimmer Cas Montreal	7	100%	OR RA	CA
17	Circle Cardiovascular Imaging, Inc. Calgary, Alberta	6	100%	RA	CA
18	Novadaq Technologies Ulc. (Now A Part of Stryker) Burnaby	6	100%	SU	CA
19	Verathon Medical (Canada) Ulc Burnaby	6	100%	EN GU	CA
20	MY01, Inc. Montreal	6	100%	OR	CA
21	Primed Medical Products, Inc. Edmonton, Alberta	5	100%	HO	CA
22	Synaptive Medical, Inc. Toronto On	5	100%	NE RA	CA
23	Panthera Dental, Inc. Quebec City	5	100%	DE	CA
24	Moleculight, Inc. Toronto	5	80%	SU	CA
25	Profound Medical, Inc. Mississauga	5	100%	GU	CA
26	Luvo Medical Technologies, Inc. Cambridge	5	100%	SU	CA
27	Molli Surgical, Inc. Toronto	5	100%	SU	CA
28	Baylis Medical Technologies, Inc. Mississauga	5	100%	CV SU	CA
29	Precision Biologic, Inc. Dartmouth, N.S.	4	100%	HE	CA
30	Scican , Ltd. Toronto	4	100%	HO	CA
31	Sekisui Diagnostics P.E.I., Inc. Prince Edward Island	4	100%	CH TX	CA
32	Zephyr Sleep Technologies Calgary	4	75%	AN DE	CA
33	Sonic Incytes Vancouver	4	100%	RA	CA
34	Flosonics Medical Toronto	4	100%	CV	CA
35	Sparrow Acoustics, Inc. Lucasville	4	100%	CV	CA
36	Inbella Medical, Inc. Richmond Hill	4	100%	SU	CA
37	Adaptiiv Medical Technologies, Inc. Halifax	3	100%	RA	CA
38	Pega Medical, Inc. Quebec	3	100%	OR	CA
39	DNA Genotek, Inc. Ottawa Ontario	3	67%	CH MI	CA
40	Medxl, Inc. Pointe-Claire	3	100%	HO	CA
41	Ventripoint Diagnostics , Ltd. Toronto	3	100%	RA	CA
42	Exact Imaging, Inc. Markham	3	100%	RA	CA
43	Change Healthcare Canada Company Richmond	3	100%	RA	CA
44	Healstone Biotech, Inc. Vancouver	3	100%	CH TX	CA
45	Limbus Ai, Inc. Regina	3	100%	RA	CA
46	Canadian Pioneer Medical Technology Corporation Vaughan	3	100%	SU	CA
47	Kane Biotech, Inc. Winnipeg	3	100%	SU	CA
48	Imeka Solutions, Inc. Sherbrooke	3	100%	RA	CA
49	Traferox Technologies, Inc. Mississauga	3	100%	GU	CA
50	Casebioscience, Inc. Guelph	2	100%	OB	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.