Omnitech Systems Inc

FDA Filings

This page includes the latest FDA filings for Omnitech Systems 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: 1835241
• FEI Number: 1000518605
• Name: OMNITECH SYSTEMS, INC.
• Owner & Operator: OMNITECH SYSTEMS, INC.
• Contact Address: 450 SOUTH CAMPBELL, SUITE 2 --; Valparaiso IN 46385 US
• Official Correspondent:
  • GREGG A VANDUSSELDORP
  • x-219-5315532-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 450 SOUTH CAMPBELL, SUITE 2 ; VALPARAISO, IN 46385 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K151976 | FAS OMNITECH SYSTEMS, INC.	Omnitech HF vaporization electrode	2016-11-23
PMN K151976 | FAS OMNITECH SYSTEMS, INC.	Omnitech HF resection electrode	2016-11-23
PMN K151976 OMNITECH SYSTEMS, INC.	Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode	2016-06-27
PMN K962538 | FAS OMNITECH SYSTEMS, INC.	Max-Blade Coagulating Resector	2013-01-28
PMN K962538 | FAS OMNITECH SYSTEMS, INC.	C-Max Cutting Loop Electrode	2013-01-28
PMN K961841 | FAS OMNITECH SYSTEMS, INC.	V-Max Roller Bar Electrode	2013-01-28
PMN K935874 | GEI OMNITECH SYSTEMS, INC.	Cook coagulator probe	2013-01-28
PMN K040390 | KQT OMNITECH SYSTEMS, INC.	Stryker Urology and Gynecology Hardware System	2013-01-28
PMN K040390 | HIH OMNITECH SYSTEMS, INC.	Stryker Urology and Gynecology Hardware System	2013-01-28
PMN K040390 | FAS OMNITECH SYSTEMS, INC.	Stryker Urology and Gynecology Hardware System	2013-01-28
PMN K040390 | FAJ OMNITECH SYSTEMS, INC.	Stryker Urology and Gynecology Hardware System	2013-01-28
PMN K981464 | KNF OMNITECH SYSTEMS, INC.	RESECTOSCOPE ROLLER	2006-05-01
PMN K981463 | KNF OMNITECH SYSTEMS, INC.	RESECTOSCOPE ROLLER	2006-05-01
PMN K050454 | FAS OMNITECH SYSTEMS, INC.	STERILE FULGURATING ELECTRODE	2006-05-01
PMN K050454 | FAS OMNITECH SYSTEMS, INC.	OMNITECH FULGURATING ELECTRODE	2006-05-01
FFL OMNITECH SYSTEMS, INC.	NITINOL WIRE BASKET	2006-05-01
FFL OMNITECH SYSTEMS, INC.	GRASPER	2006-05-01
FFL OMNITECH SYSTEMS, INC.	FLAT WIRE BASKET	2006-05-01
FFL OMNITECH SYSTEMS, INC.	Articulating Basket	2006-05-01
PMN K050454 OMNITECH SYSTEMS, INC.	OMNITECH FULGURATING ELECTRODE	2005-05-27
PMN K981463 OMNITECH SYSTEMS, INC.	OMNITECH RESECTOSCOPE ROLLER ELECTRODE	1998-07-17
PMN K981464 OMNITECH SYSTEMS, INC.	OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE	1998-07-10
PMN K964365 OMNITECH SYSTEMS, INC.	RESECTOSCOPE CUTTING LOOP ELECTRODE	1997-04-22
PMN K965093 OMNITECH SYSTEMS, INC.	OMNITECH RESECTOSCOPE ROLLER ELECTRODE	1997-03-19

Related Finance Registrations

NCAGE Code	0EX96	OMNITECH SYSTEMS INC
NCAGE Code	1QLQ6	OMNITECH SYSTEMS, INC.
CAGE Code	0EX96	OMNITECH SYSTEMS INC
CAGE Code	1QLQ6	OMNITECH SYSTEMS, INC.
S.A.M. Registration	1QLQ6 [47752618]	OMNITECH SYSTEMS, INC.