Konan Medical Usa Inc

FDA Filings

This page includes the latest FDA filings for Konan Medical Usa 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: 3005955744
• FEI Number: 3005955744
• Name: KONAN MEDICAL USA, INC.
• Owner & Operator: KONAN MEDICAL USA, INC.
• Contact Address: 15770 LAGUNA CANYON ROAD SUITE 150; Irvine CA 92618 US
• Official Correspondent:
  • DALE SADLIK
  • x-949-5762200-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 15770 Laguna Canyon Road Suite 150; Irvine, CA 92618 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04582275270068 KONAN MEDICAL USA, INC.		2023-06-23
GUDID 04582275270051 KONAN MEDICAL USA, INC.	N/A	2019-09-17
GUDID 04582275270020 KONAN MEDICAL USA, INC.		2018-07-06
GUDID 04582275270044 KONAN MEDICAL USA, INC.		2018-03-29
GUDID 04582275270037 KONAN MEDICAL USA, INC.		2018-03-29
PMN K081591 | GWE KONAN MEDICAL USA, INC.	EVOKEDx	2015-03-27
HIT KONAN MEDICAL USA, INC.	COLORDx CCT HD	2013-08-05
HRI KONAN MEDICAL USA, INC.	EYEKINETIX	2011-11-07

Related Finance Registrations

CAGE Code	4VKY7	KONAN MEDICAL USA, INC. KONAN MEDICAL
S.A.M. Registration	4VKY7 [788439219]	KONAN MEDICAL USA, INC.
SEC	0001470584	Konan Medical USA, Inc. of CALIFORNIA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020042760560	Yantian,China (Mainland) -> Los Angeles, California	INSTRUMENT TABLE	48 CTN
2019022053389	Yantian,China (Mainland) -> Los Angeles, California	INSTRUMENT TABLE	32 CTN
2018100143834	Shanghai ,China (Mainland) -> Long Beach, California	INSTRUMENT TABLE	50 CTN