Omniguide, Inc. is one of 16330 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Omniguide, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OmniGuide BeamPath OTO-U Fiber, TRIO Handpiece, Beacon Advanced CO2 Laser System
14
Total
14
Cleared
0
Denied
Omniguide, Inc. has 14 FDA 510(k) cleared general & plastic surgery devices. Based in Cambridge, US.
Last cleared in 2021. Active since 2006.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Omniguide, Inc.
14 devices
Cleared
Jan 14, 2021
OmniGuide BeamPath OTO-U Fiber
General & Plastic Surgery
72d
Cleared
May 02, 2019
TRIO Handpiece
General & Plastic Surgery
164d
Cleared
Jun 28, 2018
Beacon Advanced CO2 Laser System
General & Plastic Surgery
73d
Cleared
Sep 25, 2014
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
General & Plastic Surgery
223d
Cleared
Nov 20, 2009
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
General & Plastic Surgery
15d
Cleared
Oct 29, 2009
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
General & Plastic Surgery
13d
Cleared
Aug 12, 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
General & Plastic Surgery
35d
Cleared
Jan 02, 2008
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
General & Plastic Surgery
37d
Cleared
Dec 14, 2007
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
General & Plastic Surgery
10d
Cleared
Feb 01, 2007
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
General & Plastic Surgery
15d
Cleared
Jan 25, 2007
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
General & Plastic Surgery
17d
Cleared
Nov 29, 2006
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
General & Plastic Surgery
44d