Ohk Medical Devices L T D

FDA Filings

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

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

• Registration Number: 3003889520
• FEI Number: 3003889520
• Name: OHK MEDICAL DEVICES LTD
• 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
• US Agent:
  • Igor Naroditsky
  • OHK Medical Devices Inc.
  • 866 4306132
  • 866 4306132
  • igorn2007@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4 Etgar street ; Tirat Carmel Ha Zafon, 3903215 IL
• Establishment Type: Manufacture Medical Device

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
GEC 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
GAX OHK MEDICAL DEVICES LTD	HemaShock, Medical apparatus for use in emergency medicine procedures.	2008-02-15
GAX OHK MEDICAL DEVICES LTD	HemaClear Sterile Surgical Tourniquet	2008-02-15

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
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