Kaneka Pharma America L L C

FDA Filings

This page includes the latest FDA filings for Kaneka Pharma America L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Kaneka Pharma America L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)

Registration Number	2435151
FEI Number	2435151
Name	KANEKA PHARMA AMERICA LLC
Owner & Operator	KANEKA CORP.
Contact Address	2-3-18, Nakanoshima, Kita-ku Osaka JP-27 Osaka 530-8288 JP
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	546 FIFTH AVE., 21ST FLOOR New York, NY 10036 US

FDA Filings

Device Company	Device	Date
PMN K192068 Kaneka Pharma America LLC	I-ED COIL	2020-04-25
GUDID 18855036020688 KANEKA PHARMA AMERICA LLC	TUBING SYSTEM FOR PLASMAPHERESIS	2018-09-21
GUDID 14537693900636 KANEKA PHARMA AMERICA LLC	SULFLUX	2018-05-30
GUDID 18855036012850 KANEKA PHARMA AMERICA LLC	TUBING SYSTEM FOR PLASMAPHERESIS	2018-05-29
GUDID 04987671040374 KANEKA PHARMA AMERICA LLC	APHERESIS MACHINE	2018-05-29
PMN K170247 KANEKA PHARMA AMERICA LLC	Lacriflow CL	2017-04-18
PMN K121301 KANEKA PHARMA AMERICA LLC	XPRESSWAY RX CATHETER (6F LD-VERISON)	2012-07-30
PMN K101839 KANEKA PHARMA AMERICA LLC	KANEKA PHARMA AMERICA XPRESS-WAY RX	2010-10-22

Similar & Related FDA Registered Companies

KANEKA PHARMA AMERICA CORP.546 Fifth Ave., 21st Floornew York, NY 10036 PMA NumberP910018 Supplement NumberS034 Date Received05/31/2022 Decision Date06/30/2022 Product Code MMY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
KANEKA PHARMA AMERICA CORP.546 Fifth Ave., 21st Floornew York, NY 10036 PMA NumberP910018 Supplement NumberS033 Date Received03/30/2022 Decision Date04/29/2022 Product Code MMY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	5JPV9	KANEKA PHARMA AMERICA LLC
CAGE Code	5JPV9	KANEKA PHARMA AMERICA LLC
S.A.M. Registration	5JPV9 [136605362]	KANEKA PHARMA AMERICA LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082422947	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5112 PKG
2020082422947	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5112 PKG
2020061827898	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5250 PKG
2020061827898	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5250 PKG
202005161456	Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	4530 PKG
202005161456	Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	4530 PKG
2020022725002	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5250 PKG
2020022725002	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5250 PKG
2019122720472	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5328 PKG
2019122720472	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	5328 PKG
2019101815340	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	4608 PKG
2019101815340	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	4608 PKG
201908303563	Pusan,South Korea -> New York, New York	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	4440 PCS
2019081523105	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL	24 PCS