Omniguide Inc

FDA Filings

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

Omniguide Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3005350457
FEI Number3005350457
NameOMNIGUIDE, INC.
Owner & OperatorOMNIGUIDE, INC.
Contact Address4 Maguire Rd
Lexington MA 02421 US
Official Correspondent
  • Samuel Wade
  • x-617-5518410-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4 Maguire Rd
Lexington, MA 02421 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
OMNIGUIDE, INC.
 Velocity™ High Performance Fiber 3320052021-04-07
OMNIGUIDE, INC.
 Omniguide Select Fiber 3220032021-04-07
OMNIGUIDE, INC.
 Elevate™ ENT Elite Fiber 3220012021-04-07
OMNIGUIDE, INC.
 BeamPath ROBOTIC fiber ROBOTIC2021-04-07
OMNIGUIDE, INC.
 BeamPath NEURO-L Fiber NEURO-L2021-04-07
OmniGuide, Inc.
OmniGuide BeamPath OTO-U Fiber2021-01-14
OMNIGUIDE, INC.
 TRIO Handpiece 3230002019-06-14
OMNIGUIDE, INC.
 Beacon Advanced Energy CO2 Laser System 420060-AA2019-06-06
OMNIGUIDE, INC.
TRIO Handpiece2019-05-30
OMNIGUIDE, INC.
TRIO Handpiece2019-05-30
OmniGuide, Inc.
TRIO Handpiece2019-05-02
OMNIGUIDE, INC.
 Gas Filter Unit ACC-GFU-1002018-07-06
OMNIGUIDE, INC.
 GYN MIS Robotic & Laparoscopic Instrumentation Set GYN-HS-MIS2018-07-06
OMNIGUIDE, INC.
 FlexGuide ULTRA with Tray FLEX-ULTRA SET2018-07-06
OMNIGUIDE, INC.
 ELEVATE™ ENT Instrumentation Set - 11 3210162018-07-06
OMNIGUIDE, INC.
 BeamPath OTO Handpiece Set OTO-HS2018-07-06
OMNIGUIDE, INC.
 BeamPath NEURO Handpiece Set NEURO-HS2018-07-06
OMNIGUIDE, INC.
 ELEVATE™ ENT Instrumentation Set - 13 3210152018-07-06
OMNIGUIDE, INC.
 BeamPath GYN-LGT Handpiece Set GYN-HS-LGT2018-07-06
OMNIGUIDE, INC.
 BeamPath GYN-LAP Handpiece Set GYN-HS-LAP-12018-07-06
OMNIGUIDE, INC.
 OmniGuide® OmniFlex Instrument Set 3410042018-07-06
OMNIGUIDE, INC.
 OmniGuide® LapFlex Instrument Set 3410032018-07-06
OMNIGUIDE, INC.
 GYN Handpiece Mark III, 13 cm Bent GYN-HP-13B2018-07-06
OMNIGUIDE, INC.
 GYN Handpiece Mark III, 13 cm GYN-HP-132018-07-06
OMNIGUIDE, INC.
 GYN Handpiece Mark III, 6 cm Bent GYN-HP-6B2018-07-06
OMNIGUIDE, INC.
 GYN Handpiece, 3.5 cm, Straight GYN-HP-3.52018-07-06
OMNIGUIDE, INC.
 GYN Handpiece Mark III, 6 cm GYN-HP-62018-07-06
OMNIGUIDE, INC.
 GYN-Laparoscopic Handpiece, 29 cm, Straight GYN-HP-292018-07-06
OMNIGUIDE, INC.
 GYN-LAP Handpiece, 33cm, Bent GYN-LAP-33B2018-07-06
OMNIGUIDE, INC.
 GYN Handpiece, 46 cm, Straight GYN-HP-462018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece, 10cm, Bent NEURO-HP-10B2018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece, 8cm, Straight NEURO-HP-82018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece, 8cm, Bent NEURO-HP-8B2018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece, 6cm, Bent NEURO-HP-6B2018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece, 5cm, Straight NEURO-HP-52018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece, 3.5cm, Straight NEURO-HP-3.52018-07-06
OMNIGUIDE, INC.
 GYN-LAP Handpiece Tray GYN-TRAY-LAP-12018-07-06
OMNIGUIDE, INC.
 GYN-LGT Handpiece Tray GYN-TRAY-LGT2018-07-06
OMNIGUIDE, INC.
 GYN Robotic Handpiece Tray GYN-TRAY-MIS2018-07-06
OMNIGUIDE, INC.
 Core GYN Tray 3410052018-07-06
OMNIGUIDE, INC.
 NEURO Handpiece Tray NEURO-TRAY2018-07-06
OMNIGUIDE, INC.
 FLEXGUIDE-ULTRA Handpiece Tray FLEX-TRAY2018-07-06
OMNIGUIDE, INC.
 OmniGuide® LapFlex Tray 3410022018-07-06
OMNIGUIDE, INC.
 Elevate™ ENT Instrumentation Tray 3210142018-07-06
OmniGuide, Inc
Beacon Advanced CO2 Laser System2018-06-28
OMNIGUIDE, INC.
Beacon Advanced Energy Laser System2018-06-28
OMNIGUIDE, INC.
OmniGuide Laser System with FlexGuide Ultra2014-11-17
OMNIGUIDE, INC.
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT2014-09-25
OMNIGUIDE, INC.
OTO-S2012-11-19
OMNIGUIDE, INC.
OTO-M2012-11-19
OMNIGUIDE, INC.
Lower Genital Procedure Tray2012-11-19
OMNIGUIDE, INC.
Lower Genital Handpiece2012-11-19
OMNIGUIDE, INC.
Laparoscopic Procedure Tray2012-11-19
OMNIGUIDE, INC.
Laparoscopic Handpiece2012-11-19
OMNIGUIDE, INC.
GYN-LAP-33B2012-11-19
OMNIGUIDE, INC.
GYN-HP-462012-11-19
OMNIGUIDE, INC.
GYN-HP-292012-11-19
OMNIGUIDE, INC.
FlexGuide Ultra Tray2012-11-19
OMNIGUIDE, INC.
FlexGuide Ultra Robotic Fiber Conduit2012-11-19
OMNIGUIDE, INC.
Elevate ENT Instrumentation Tray2012-11-19
OMNIGUIDE, INC.
Elevate ENT Handpiece2012-11-19
OMNIGUIDE, INC.
ENT Handpiece2012-11-19
OMNIGUIDE, INC.
ENT Handpiece Tray2012-11-19
OMNIGUIDE, INC.
ENT Handpiece Set2012-11-19
OMNIGUIDE, INC.
BeamPath Robotic Fiber Conduit2012-11-19
OMNIGUIDE, INC.
BeamPath OTO Handpiece2012-11-19
OMNIGUIDE, INC.
BeamPath OTO Handpiece Set2012-11-19
OMNIGUIDE, INC.
BeamPath Neuro Handpiece Straight2012-11-19
OMNIGUIDE, INC.
BeamPath Neuro Handpiece Set2012-11-19
OMNIGUIDE, INC.
BeamPath Neuro Handpiece Bayonet2012-11-19
OMNIGUIDE, INC.
BeamPath CO2 Laser Fiber Surgical Handpiece2012-11-19
OMNIGUIDE, INC.
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP2009-11-20
OMNIGUIDE, INC.
Intelliguide Laser System2009-11-20
OMNIGUIDE, INC.
Fiber Enabled Laser System2009-11-20
OMNIGUIDE, INC.
FELS-25A2009-11-20
OMNIGUIDE, INC.
C-Las FELS-25A-LS2009-11-20
OMNIGUIDE, INC.
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM2009-10-29
OMNIGUIDE, INC.
Gas Filter Unit2008-08-13
OMNIGUIDE, INC.
Velocity? Fiber2008-08-13
OMNIGUIDE, INC.
Elevate Elite ENT Fiber2008-08-13
OMNIGUIDE, INC.
Elevate ENT Fiber2008-08-13
OMNIGUIDE, INC.
BeamPath NEURO-L Fiber2008-08-13
OMNIGUIDE, INC.
BeamPath GYN-L Fiber2008-08-13
OMNIGUIDE, INC.
BeamPath ENT-L Fiber2008-08-13
OMNIGUIDE, INC.
BeamPath BP-Robotic Fiber2008-08-13
OMNIGUIDE, INC.
BeamPath BP-LE Fiber2008-08-13
OMNIGUIDE, INC.
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY2008-08-12
OMNIGUIDE, INC.
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP2008-01-02
OMNIGUIDE, INC.
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM2007-12-14
OMNIGUIDE, INC.
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER2007-02-01
OMNIGUIDE, INC.
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER2007-01-25
OMNIGUIDE, INC.
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER2006-11-29
OMNIGUIDE, INC.
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM2006-09-21
OMNIGUIDE, INC.
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-002006-07-19

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code596H7OMNIGUIDE, INC.
CAGE Code596H7OMNIGUIDE, INC.
S.A.M. Registration596H7 [30124221]OMNIGUIDE, INC.
DUNS030124221Omniguide, Inc.
SEC0001375119OMNIGUIDE INC of DELAWARE
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