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

Filter by country or FDA review panel specialty

Canada FDA 510(k) Overview

531

Manufacturers

1,660

Submissions

99%

Clearance rate

Leading Canada FDA 510(k) manufacturers include Diagnostic Chemicals , Ltd., Excel Tech. , Ltd., Synermed, Inc. and 528 others.

Canadian medical device manufacturers have submitted 1,660 FDA 510(k) notifications since 1985, with a 98.6% clearance rate. Canada's medtech sector is well-integrated with the U.S. regulatory pathway, with 531 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 531

#	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	20	100%	OR RA	CA
10	Precision Biologicals, Inc. Dartmouth	20	100%	HE MI	CA
11	Imaging Dynamics Company , Ltd. Calgary, Alberta	19	100%	RA	CA
12	Madsen Electronics (Canada) , Ltd. Oakville, Ontario	17	100%	EN GU NE	CA
13	Cyberfluor, Inc. Ontario M5t 1x4	17	100%	CH HE IM +2	CA
14	Bodycad Laboratories, Inc. Quebec City	16	100%	OR	CA
15	Novadaq Technologies, Inc. Mississauga, Ontario	15	100%	GU RA SU	CA
16	Orthosoft, Inc. Montreal, Quebec	14	100%	NE OR	CA
17	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Oakville	13	100%	EN NE OP	CA
18	Clarius Mobile Health Corp. Vancouver	12	100%	RA	CA
19	Trudell Medical Intl. London	12	100%	AN	CA
20	Spectral Diagnostics, Inc. Toronto, Ontario	12	92%	CH MI	CA
21	Pega Medical, Inc. Quebec	12	100%	OR	CA
22	Ultrasonix Medical Corporation Vancouver, Bc	11	100%	AN RA	CA
23	Scican , Ltd. Toronto	11	100%	DE HO	CA
24	Starplex Scientific, Inc. Etobicoke, Ontario	10	100%	CH MI TX	CA
25	Precision Biologic Dartmouth, N.S.	10	100%	HE	CA
26	Primed Medical Products, Inc. Edmonton, Alberta	10	100%	HO	CA
27	Natus Medical Incorporated Oakville, Ontario	10	100%	EN HO NE +1	CA
28	Synaptive Medical, Inc. Toronto On	10	100%	NE RA	CA
29	Opsens, Inc. Quebec	10	100%	CV	CA
30	Andronic Devices, Ltd. Richmond,B.C. V6v-2j2	9	100%	CH HO NE +2	CA
31	Dumex Medical Surgical Products, Ltd. Toronto, Orntario	9	78%	HO SU	CA
32	Primeline Medical Products, Inc. Edmonton, Alberta	9	100%	HO SU	CA
33	Cardiocomm Solutions, Inc. Victoria, B.C.	9	100%	CV	CA
34	Motion Concepts Concord, Ontario	9	100%	PM	CA
35	Circle Cardiovascular Imaging, Inc. Calgary, Alberta	9	100%	RA	CA
36	Trudell Medical International London	9	100%	AN	CA
37	7D Surgical, Inc. Toronto	9	100%	NE OR	CA
38	Ophthalmic Technologies, Inc. Downsview, Ontario	8	100%	OP RA	CA
39	Braebon Medical Corp. Carp, Ontario	8	100%	AN NE	CA
40	Ind Diagnostic, Inc. Delta, B.C.	8	100%	CH HE TX	CA
41	O-Two Medical Technologies, Inc. Mississauga	8	100%	AN	CA
42	Pdg Product Design Group, Inc. Vancouver, Bc	8	100%	PM	CA
43	Calgary Scientific, Inc. Calgary, Alberta	8	100%	RA	CA
44	Innovative Bioceramix, Inc. Vancouver, Bc	8	100%	DE	CA
45	Monteris Medical, Inc. Winnipeg, Mb	8	100%	NE RA SU	CA
46	DNA Genotek, Inc. Ottawa Ontario	8	88%	CH MI	CA
47	Itena Clinical Laval	8	100%	DE	CA
48	International Newtech Development, Inc. Richmond, B.C.	7	100%	CH	CA
49	Mds Nordion Ottawa	7	100%	RA	CA
50	Is2 Research, Inc. Nepean, Ontario	7	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.