Baylis Medical Company, Inc. is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Baylis Medical Company, Inc. - FDA 510(k) Cleared Devices
Recent clearances: VersaCross Connect™ Transseptal Dilator, VersaCross Connect™ Transseptal Dilator, SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
24
Total
24
Cleared
0
Denied
Baylis Medical Company, Inc. has 24 FDA 510(k) cleared medical devices. Based in Mississauga, Ontario, CA.
Latest FDA clearance: May 2025. Active since 2012. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Baylis Medical Company, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Baylis Medical Company, Inc.
24 devices
Cleared
May 29, 2025
VersaCross Connect™ Transseptal Dilator
Cardiovascular
30d
Cleared
Jul 12, 2024
VersaCross Connect™ Transseptal Dilator
Cardiovascular
28d
Cleared
Dec 20, 2023
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Cardiovascular
236d
Cleared
Dec 14, 2023
VersaCross Connect™ Transseptal Dilator
Cardiovascular
30d
Cleared
Mar 01, 2023
ProTrack Pigtail Wire
Cardiovascular
442d
Cleared
Dec 19, 2022
Mechanical Guidewire
Cardiovascular
223d
Cleared
Jun 30, 2022
Epicardial Access System
Cardiovascular
230d
Cleared
May 09, 2022
VersaCross Connect Transseptal Dilator
Cardiovascular
84d
Cleared
Jun 12, 2020
ExpanSure Large Access Transseptal Dilator
Cardiovascular
29d
Cleared
Aug 02, 2019
Epicardial Access System
Cardiovascular
51d
Cleared
Jun 07, 2019
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic...
Cardiovascular
163d
Cleared
Jun 07, 2019
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
Cardiovascular
163d
Cleared
May 20, 2019
VersaCross Transseptal Sheath
Cardiovascular
144d
Cleared
Apr 17, 2019
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
Cardiovascular
30d
Cleared
Mar 21, 2019
ExpanSure Transseptal Dilation System
Cardiovascular
232d
Cleared
Jan 02, 2019
Polaris RF Ablation System
Neurology
174d
Cleared
Jan 31, 2017
OsteoCool V-3 RF Ablation System
General & Plastic Surgery
200d
Cleared
Sep 26, 2016
PORTAGE System
Orthopedic
80d
Cleared
Nov 24, 2015
OsteoCool V-3 RF Ablation System
General & Plastic Surgery
123d
Cleared
Aug 18, 2015
Nexus Suture
General & Plastic Surgery
125d
Cleared
Jun 17, 2015
ProTrack RF Anchor Wire
Cardiovascular
90d
Cleared
Jun 16, 2015
OsteoCool V-2 RF Ablation System
General & Plastic Surgery
285d
Cleared
Aug 30, 2013
BAYLIS MEDICAL RF PERFORATION PROBE V2.0
General & Plastic Surgery
31d
Cleared
Nov 07, 2012
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
General & Plastic Surgery
100d