FDA.reportPublic FDA data

Kaneka Medical America LLC

Matched from indexed company URL: KANEKA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24351512435151Kaneka Medical America LLC1Y2026-01-01623 Fifth Avenue New York NY US 10022
30097615733009761573KANEKA MEDIX CORPORATION KANAGAWA PLANT1N2026-01-01225-1 Aza Deguchi, Yamakita Yamakita-machi Ashigara-Kami-gun Kanagawa JP 2580113
30147587553014758755KANEKA AMERICAS HOLDING INC1N2026-01-017979 Gateway Blvd Newark CA US 94560
30315509703031550970KANEKA MEDICAL VIETNAM Co.,Ltd.1N2026-01-0135 VSIP Street 6, Vietnam - Singapore Industrial Park, An Phu Wo Ho Chi Minh VN NA

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04540778177086i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778177116i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778193710i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778193727i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3475381430585149K251668SurfRider 13 MicrocatheterQJP2026-01-05
1446121888905219K210638i-ED COIL SystemHCG2021-03-26
3285181888905219K210638i-ED COIL SystemHCG2021-03-26
3285181669513610K172264OTW Takeru PTCA Balloon Dilatation CatheterLOX2018-03-19
3285181642200737K170941RX NC Takeru PTCA Balloon Dilatation CatheterLOX2017-07-07
1446121996704147K170247Lacriflow CLOKS2017-04-18
3285181653217226K163372RX Takeru Balloon Dilatation CatheterLOX2017-04-07
1446121710466092K121301XPRESSWAY RX CATHETER (6F LD-VERISON)QEZ2012-07-30
1446121890717006K120886LACRIFASTOKS2012-12-17
1446121118856797K101839KANEKA PHARMA AMERICA XPRESS-WAY RXQEZ2010-10-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX32018-03-19
HCG22021-03-26
OKS22017-04-18
QEZ22012-07-30
QJP12026-01-05

PMA#

LIPOSORBER LA-15 System

2022-06-30

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 Supple...

LIPOSORBER LA-15 System

2022-04-29

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 Supple...

PMN#

GUDID#

200 records. Showing 1-40. Next