Lumitex Md Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1000122810
• FEI Number: 1000122810
• Name: Lumitex Medical Devices Inc.
• Owner & Operator: LUMITEX MD, INC.
• Contact Address: 8443 DOW CIR. --; Strongsville OH 44136 US
• Official Correspondent:
  • Kimberly S Tetuan
  • x-440-2438401-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8300 Dow Circle Suite 400 ; Strongsville, OH 44136 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

• Registration Number: 1528108
• FEI Number: 1000122810
• Name: LUMITEX Medical Devices, INC.
• Owner & Operator: LUMITEX MD, INC.
• Contact Address: 8443 DOW CIR. --; Strongsville OH 44136 US
• Official Correspondent:
  • Kimberly S Tetuan
  • x-440-2438401-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8443 DOW CIR. --; Strongsville, OH 44136 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K120820 | LBI Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Giraffe Blue Spot PT Lite	2013-01-22
PMN K120820 | LBI LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]	Giraffe Blue Spot PT Lite	2013-01-22
PMN K053568 | LBI Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bilisoft Phototherapy System	2009-05-07
PMN K053568 | LBI Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, Small Pad	2009-05-07
PMN K053568 | LBI Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, Large Pad	2009-05-07
PMN K053568 | LBI Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, English Small Pad	2009-05-07
PMN K053568 | LBI Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, English Large Pad	2009-05-07
PMN K053568 | LBI LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]	Bilisoft Phototherapy System	2009-05-07
PMN K053568 | LBI LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, Small Pad	2009-05-07
PMN K053568 | LBI LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, Large Pad	2009-05-07
PMN K053568 | LBI LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, English Small Pad	2009-05-07
PMN K053568 | LBI LUMITEX Medical Devices, INC. [LUMITEX MD, INC.]	Bilisoft 2.0 Phototherapy System, English Large Pad	2009-05-07
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	iNSIte Disposable Retractor Light	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Waveguide	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	TSS RETRACTOR LIGHT STRIP	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	TLIF Retractor Light	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Synthes Spine Light Clip	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Synthes Insight Tube Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Surigcal Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Stryker Spine LITe	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Snowden-Pencer Fiber Optic Light Panel 6" (15.2 cm)	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Snowden-Pencer Fiber Optic Light Panel 5" (12.7 cm)	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Snowden-Pencer Fiber Optic Light Panel 4" (10.2 cn)	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Saphenous Vein Light Pipe	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	STARlite Surgical Illuminator 5-pack	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	STARlite Surgical Illuminator 1-pack	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Retractor Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Proview Miminal Access Portal (MAP) System- Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Port Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Panorama Port Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Oracle Enhance Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Niagara Lateral Access System	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Midline Cortical Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Malleable Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	MIS Illumination System	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	MIS Blade Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	MARS Port Illuminator - 26mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	MARS Port Illuminator - 22mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	MARS Port Illuminator - 19mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Lumiview-Mini	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Lumiview-Midi	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	LightMat	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Light Strip	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Light Clip	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Lateral Retractor Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Insight Retractor	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Illico Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	ILLICO DIRECTIONAL ILLUMINATOR	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Hind Site Light Pipe	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	GLIF Micro Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Focused Lateral Retractor Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Disposable Light Clip, Sterile	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Canyon Port Access System - 26mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Canyon Port Access System - 24mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Canyon Port Access System - 22mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Canyon Port Access System - 20mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Canyon Port Access System - 18mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Canyon Port Access System - 16mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bifurcated Light Guide	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Bifurcated Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Battalion LLIF Light Cable	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Anterior Access kit light	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Accuvison Blade Tip-25mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Accuvision Blade Tip-18mm	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Accuvision Blade 25mm x .33 Illuminated	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Accuvision Blade 25mm Flat Non-Illuminated	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Accuvision Blade 25mm Flat Illuminated	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	Accuvision Blade 18mm x .33 Illuminated	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	60mm Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	30mm Surgical Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	26mm Port Illuminator	1999-12-16
FDG Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	22mm Port Illuminator	1999-12-16
HJN Lumitex Medical Devices Inc. [LUMITEX MD, INC.]	LUMITEX NEONATAL TRANSILLUMINATOR	1994-03-11