Baylis Medical Co Inc

FDA Filings

This page includes the latest FDA filings for Baylis Medical Co Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004572127
FEI Number3004572127
NameBAYLIS MEDICAL COMPANY INC.
Owner & OperatorBAYLIS MEDICAL COMPANY INC.
Contact Address5959 TRANS-CANADA HIGHWAY --
SAINT-LAURENT, QUEBEC CA-NOTA H4T 1A1 CA
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1320 ROUTE 9
CHAMPLAIN, NY 12919 US

Registration Number9710452
FEI Number3000157372
NameRene van de Zande
Owner & OperatorBAYLIS MEDICAL COMPANY INC.
Contact Address5959 TRANS-CANADA HIGHWAY --
SAINT-LAURENT, QUEBEC CA-NOTA H4T 1A1 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Baylis Medical Company Inc.
Epicardial Access System2022-06-30
Baylis Medical Company Inc.
ExpanSure Large Access Transseptal Dilator2020-06-12
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
VersaCross Transseptal Dilator2019-09-11
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
VersaCross Steerable Sheath2019-09-11
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
EPstar Fixed Electrophysiology Catheter2019-08-20
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
EPstar Electrophysiology Cable2019-08-20
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
EPstar Fixed Electrophysiology Catheter with Lumen2019-08-20
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
EPstar Electrophysiology Cable2019-08-20
Baylis Medical Company Inc.
Epicardial Access System2019-08-02
Baylis Medical Company Inc.
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable2019-06-07
Baylis Medical Company Inc.
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable2019-06-07
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
VersaCross Transseptal Sheath2019-06-06
Baylis Medical Company Inc.
VersaCross Transseptal Sheath2019-05-20
Baylis Medical Company Inc.
VersaCross Steerable Sheath, VersaCross Transseptal Dilator2019-04-17
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG Large Access Solution2019-04-03
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
ExpanSure Large Access Transseptal Dilator2019-04-03
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG Large Access Solution2019-04-03
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
ExpanSure Large Access Transseptal Dilator2019-04-03
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG Large Access Solution2019-04-03
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
ExpanSure Large Access Transseptal Dilator2019-04-03
Baylis Medical Company Inc.
ExpanSure Transseptal Dilation System2019-03-21
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Single Use RF Probe2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Reusable RF Probe2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian RF Cannula2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Enhanced RF Probe Kit2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Enhanced RF Introducer2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Single Use RF Probe2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Reusable RF Probe2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian RF Cannula2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Enhanced RF Probe Kit2019-02-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Accurian Enhanced RF Introducer2019-02-22
Baylis Medical Company Inc.
Polaris RF Ablation System2019-01-02
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Powerwire Radiofrequency Guidewire Kit2017-05-24
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
OsteoCool RF Ablation Probe Kit2017-02-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
OsteoCool Independent Thermocouple Kit2017-02-28
Baylis Medical Company Inc.
OsteoCool V-3 RF Ablation System2017-01-31
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorView? Endoscope2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorKnot? Tissue Approximation Kit2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorKnot? Suture Passer (2-0)2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorKnot? Knot Pusher (2-0) and AnchorKnot? Suture Cutter (2-0)2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Expander Blades, 80mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Expander Blades, 70mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Expander Blades, 60mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Expander Blades, 50mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Double Flange, 80mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Double Flange, 70mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Double Flange, 60mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, Double Flange, 50mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, 80mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, 70mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, 60mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorEntry? Retractor, 50mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? Track Dilator, 19mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? Cobb Elevator, 19mm, Retention Ring2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? Cobb Elevator, 19mm, Handle2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? Cobb Elevator, 19mm, Blade2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? #4 Dilator, 19mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? #3 Dilator2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? #2 Dilator2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorAccess? #1 Dilator2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Up Cutting Straight Curette, 3x5mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor System2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Screwdriver2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Rotating Knob/Ring, Retractor2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Narrow Penfield Probe, 3mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Hex L-Wrench, 5mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Handle, Retractor2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Endoscope Bracket2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Down Cutting Straight Curette, 3x5mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Curved Tip Kerrison Rongeur2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor Curved Tip Ball Probe, 1.7mm Dia2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor 90 Deg Ball Probe, 1.7mm Dia2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor 2mm Disc Forceps Up Biting2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor 2mm Disc Forceps Straight2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor 20 Deg Oval End Gouge, 3x5mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Anchor 10 Deg Back Oval Curette, 3x5mm2016-11-28
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
AnchorKnot? Suture2016-11-28
Baylis Medical Company Inc.
PORTAGE System2016-09-26
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
OsteoCool RF Ablation Probe Kit2015-12-23
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
OsteoCool Independent Thermocouple Kit2015-12-23
BAYLIS MEDICAL COMPANY INC.
OsteoCool V-3 RF Ablation System2015-11-24
BAYLIS MEDICAL COMPANY INC.
Nexus Suture2015-08-18
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
VersaCross RF Wire2015-07-31
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
SupraCross RF Wire2015-07-31
BAYLIS MEDICAL COMPANY INC.
ProTrack RF Anchor Wire2015-06-17
BAYLIS MEDICAL COMPANY INC.
OsteoCool V-2 RF Ablation System2015-06-16
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
DuoMode Cable2014-12-01
BAYLIS MEDICAL COMPANY INC.
BAYLIS MEDICAL RF PERFORATION PROBE V2.02013-08-30
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Protrack Pigtail Wire2013-05-14
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
SureFlex Steerable Guiding Sheath2013-01-31
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
SupraCross Steerable Sheath2013-01-31
BAYLIS MEDICAL CO., INC.
SUREFLEX STEERABLE GUIDING SHEATH KIT2013-01-24
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
RFP-100A Footswitch2012-11-22
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Baylis Medical Company Radiofrequency Perforation Generator2012-11-22
BAYLIS MEDICAL COMPANY INC.
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR2012-11-07
BAYLIS MEDICAL CO., INC.
OSTEOCOOL (TM) RF ABLATION SYSTEM2012-03-13
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
TorFlex Transseptal Guiding Sheath2011-04-13
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG RF Transseptal Kit2011-04-13
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
TorFlex Transseptal Guiding Sheath2011-04-13
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG RF Transseptal Kit2011-04-13
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
TorFlex Transseptal Guiding Sheath2011-04-13
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG RF Transseptal Kit2011-04-13
BAYLIS MEDICAL CO., INC.
TORFLEX TRANSSEPTAL GUIDING SHEATH2011-04-01
BAYLIS MEDICAL CO., INC.
INDISCAL DIGITAL MANOMETER2011-02-23
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
PowerWire Radiofrequency GuideWire2010-08-23
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
PowerWire Radiofrequency GuideWire Kit2010-08-23
BAYLIS MEDICAL CO., INC.
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-202010-08-10
BAYLIS MEDICAL CO., INC.
POWERWIRE RADIOFREQUENCY GUIDEWIRE2010-07-28
BAYLIS MEDICAL CO., INC.
LEV-OR DILATION CATHETER OTW2010-07-16
BAYLIS MEDICAL CO., INC.
INDISCAL ASPIRATION DEVICE AND ACCESSORIES2009-11-17
BAYLIS MEDICAL CO., INC.
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS2009-10-16
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG Transseptal Needle2008-12-01
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG RF Transseptal Kit2008-12-01
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
NRG Large Access Solution2008-12-01
BAYLIS MEDICAL CO., INC.
NRG TRANSSEPTAL NEEDLE2008-05-28
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD2007-12-19
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Nykanen Radiofrequency Wire2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
BMC Radiofrequency Puncture Generator2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
BMC Radiofrequency PuncturGenerator2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
BMC RF Cannula2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
RFP-100A Connector Cable2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
BMC Connector Cable2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Protrack Microcatheter2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
RFP-100 Footswitch2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
BMC Radiofrequency Puncture Generator2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Nykanen Radiofrequency Wire2007-11-29
Rene van de Zande [BAYLIS MEDICAL COMPANY INC.]
Nykanen Radiofrequency Wire Kit2007-11-29
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE2007-07-19
BAYLIS MEDICAL CO., INC.
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU2007-01-08
BAYLIS MEDICAL CO., INC.
RF TUNNELER WIRE2006-03-30
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-62005-11-30
BAYLIS MEDICAL CO., INC.
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-752003-12-10
BAYLIS MEDICAL CO., INC.
TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-62003-09-11
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD2003-07-17
BAYLIS MEDICAL CO., INC.
BMC CATHETER CONNECTOR CABLE, MODEL RFP-1012002-12-31
BAYLIS MEDICAL CO., INC.
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/1452002-03-07
BAYLIS MEDICAL CO., INC.
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-2302002-02-12
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)2001-05-03
BAYLIS MEDICAL CO., INC.
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-2652001-04-09
BAYLIS MEDICAL CO., INC.
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE2001-02-01
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY2000-10-23
BAYLIS MEDICAL CO., INC.
BMC RF CANNULA1998-07-17

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