Ohk Medical Devices Inc

FDA Filings

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

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

• OHK MEDICAL DEVICES LTD

FDA Registration(s)

• Registration Number: 3008062566
• FEI Number: 3008062566
• Name: OHK Medical Devices INC
• Owner & Operator: OHK Medical Devices Ltd
• Contact Address: 2885 Sanford Ave SW 14751; Grandville MI 49418 US
• Official Correspondent:
  • Igor Naroditsky
  • 1-866-5031470-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2885 Sanford Ave SW #14751 ; Grandville, MI 49418 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GAX OHK Medical Devices INC [OHK Medical Devices Ltd]	HemaClear Sterile Surgical Tourniquet	2018-12-25
GEC OHK Medical Devices INC [OHK Medical Devices Ltd]	CleaRoller, tool for spreading disinfectant solutions evenly, when preparing surgical fields	2018-12-22
GAX OHK Medical Devices INC [OHK Medical Devices Ltd]	HemaShock, Medical apparatus for use in emergency medicine procedures.	2008-02-15
GAX OHK Medical Devices INC [OHK Medical Devices Ltd]	HemaClear Sterile Surgical Tourniquet	2008-02-15

Related Finance Registrations

NCAGE Code	7F3K5	OHK MEDICAL DEVICES INC
NCAGE Code	6SY01	OHK MEDICAL DEVICES INC
CAGE Code	6SY01	OHK MEDICAL DEVICES INC
CAGE Code	7F3K5	OHK MEDICAL DEVICES INC
S.A.M. Registration	7F3K5 [54373703]	OHK MEDICAL DEVICES INC
DUNS	831771980	OHK Medical Devices Inc

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091165247	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLAC RESPIRATOR HS 902000	8 PCK
2020082964318	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLAC RESPIRATOR HS 902000	12 PCK
2020081439351	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLAC VIRIMASK RESPIRATOR HS 902000	10 PCK
2020073022138	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLAC VIRIMASK RESPIRATOR HS 90200	9 PCK
2020071551123	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLAC VIRIMASK RESPIRATOR HS 90200	9 PCK
2020051438902	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	4 PKG
2020030527089	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCTS	7 PKG
2020012015457	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TOURNIQUET	4 CTN