Lumitex Medical Devices Inc

FDA Filings

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

FDA Registration(s)
Registration Number1000122810
FEI Number1000122810
NameLumitex Medical Devices Inc.
Owner & OperatorLUMITEX MD, INC.
Contact Address8443 DOW CIR. --
Strongsville OH 44136 US
Official Correspondent
  • Kimberly S Tetuan
  • x-440-2438401-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8300 Dow Circle Suite 400
Strongsville, OH 44136 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number1528108
FEI Number1000122810
NameLUMITEX Medical Devices, INC.
Owner & OperatorLUMITEX MD, INC.
Contact Address8443 DOW CIR. --
Strongsville OH 44136 US
Official Correspondent
  • Kimberly S Tetuan
  • x-440-2438401-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8443 DOW CIR. --
Strongsville, OH 44136 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Giraffe Blue Spot PT Lite2013-01-22
LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]
Giraffe Blue Spot PT Lite2013-01-22
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bilisoft Phototherapy System2009-05-07
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, Small Pad2009-05-07
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, Large Pad2009-05-07
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, English Small Pad2009-05-07
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, English Large Pad2009-05-07
LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]
Bilisoft Phototherapy System2009-05-07
LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, Small Pad2009-05-07
LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, Large Pad2009-05-07
LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, English Small Pad2009-05-07
LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]
Bilisoft 2.0 Phototherapy System, English Large Pad2009-05-07
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
iNSIte Disposable Retractor Light1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Waveguide1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
TSS RETRACTOR LIGHT STRIP1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
TLIF Retractor Light1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Synthes Spine Light Clip1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Synthes Insight Tube Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Surigcal Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Stryker Spine LITe1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Snowden-Pencer Fiber Optic Light Panel 6" (15.2 cm)1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Snowden-Pencer Fiber Optic Light Panel 5" (12.7 cm)1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Snowden-Pencer Fiber Optic Light Panel 4" (10.2 cn)1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Saphenous Vein Light Pipe1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
STARlite Surgical Illuminator 5-pack1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
STARlite Surgical Illuminator 1-pack1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Retractor Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Proview Miminal Access Portal (MAP) System- Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Port Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Panorama Port Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Oracle Enhance Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Niagara Lateral Access System1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Midline Cortical Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Malleable Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
MIS Illumination System1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
MIS Blade Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
MARS Port Illuminator - 26mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
MARS Port Illuminator - 22mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
MARS Port Illuminator - 19mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Lumiview-Mini1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Lumiview-Midi1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
LightMat1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Light Strip1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Light Clip1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Lateral Retractor Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Insight Retractor1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Illico Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
ILLICO DIRECTIONAL ILLUMINATOR1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Hind Site Light Pipe1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
GLIF Micro Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Focused Lateral Retractor Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Disposable Light Clip, Sterile1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Canyon Port Access System - 26mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Canyon Port Access System - 24mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Canyon Port Access System - 22mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Canyon Port Access System - 20mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Canyon Port Access System - 18mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Canyon Port Access System - 16mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bifurcated Light Guide1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Bifurcated Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Battalion LLIF Light Cable1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Anterior Access kit light1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Accuvison Blade Tip-25mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Accuvision Blade Tip-18mm1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Accuvision Blade 25mm x .33 Illuminated1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Accuvision Blade 25mm Flat Non-Illuminated1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Accuvision Blade 25mm Flat Illuminated1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
Accuvision Blade 18mm x .33 Illuminated1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
60mm Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
30mm Surgical Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
26mm Port Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
22mm Port Illuminator1999-12-16
Lumitex Medical Devices Inc. [LUMITEX MD, INC.]
LUMITEX NEONATAL TRANSILLUMINATOR1994-03-11

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