Kaneka Medical America LLC

Matched from indexed company URL: KANEKA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2435151	2435151	Kaneka Medical America LLC	1	Y	2026-01-01	623 Fifth Avenue New York NY US 10022
3009761573	3009761573	KANEKA MEDIX CORPORATION KANAGAWA PLANT	1	N	2026-01-01	225-1 Aza Deguchi, Yamakita Yamakita-machi Ashigara-Kami-gun Kanagawa JP 2580113
3014758755	3014758755	KANEKA AMERICAS HOLDING INC	1	N	2026-01-01	7979 Gateway Blvd Newark CA US 94560
3031550970	3031550970	KANEKA MEDICAL VIETNAM Co.,Ltd.	1	N	2026-01-01	35 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 GUDID	Product	Phone	Email
04540778177086	i-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) 526-3522	xx@xx.xx
04540778177116	i-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) 526-3522	xx@xx.xx
04540778193710	i-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) 526-3522	xx@xx.xx
04540778193727	i-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) 526-3522	xx@xx.xx

xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
347538	1430585149	K251668	SurfRider 13 Microcatheter	QJP	2026-01-05
144612	1888905219	K210638	i-ED COIL System	HCG	2021-03-26
328518	1888905219	K210638	i-ED COIL System	HCG	2021-03-26
328518	1669513610	K172264	OTW Takeru PTCA Balloon Dilatation Catheter	LOX	2018-03-19
328518	1642200737	K170941	RX NC Takeru PTCA Balloon Dilatation Catheter	LOX	2017-07-07
144612	1996704147	K170247	Lacriflow CL	OKS	2017-04-18
328518	1653217226	K163372	RX Takeru Balloon Dilatation Catheter	LOX	2017-04-07
144612	1710466092	K121301	XPRESSWAY RX CATHETER (6F LD-VERISON)	QEZ	2012-07-30
144612	1890717006	K120886	LACRIFAST	OKS	2012-12-17
144612	1118856797	K101839	KANEKA PHARMA AMERICA XPRESS-WAY RX	QEZ	2010-10-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LOX	3	2018-03-19
HCG	2	2021-03-26
OKS	2	2017-04-18
QEZ	2	2012-07-30
QJP	1	2026-01-05

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...
LIPOSORBER LA-15 System
2022-01-14
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 System
2021-07-28
KANEKA PHARMA AMERICA CORP.
LIPOSORBER® LA-15 System
2021-04-29
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 System
2020-12-22
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 System
2020-04-21
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 System
2019-05-22
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 System
2019-03-28
KANEKA PHARMA AMERICA CORP.
Liposorber LA-15 System
2018-04-12
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 System
2018-03-26
KANEKA PHARMA AMERICA CORP.
LIPOSORBER(R) LA-15 SYSTEM
2017-05-23
KANEKA PHARMA AMERICA CORP.
LIPOSORBER(R) LA-15 SYSTEM
2016-10-14
KANEKA PHARMA AMERICA CORP.
LIPOSORBER® LA-15 SYSTEM
2016-09-23
KANEKA PHARMA AMERICA CORP.
LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
2016-04-19
KANEKA PHARMA AMERICA CORP.
LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
2016-03-10
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2015-07-15
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2012-06-19
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2012-05-03
KANEKA PHARMA AMERICA CORP.
BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM
2010-06-18
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2009-03-31
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2007-06-27
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2003-03-06
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2003-02-14
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2002-04-09
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
2000-12-06
KANEKA PHARMA AMERICA CORP.
LIPOSORBER(R) LA-15 SYSTEM
2000-08-21
KANEKA PHARMA AMERICA CORP.
LIPOSORBER LA-15 SYSTEM
1999-10-29
KANEKA PHARMA AMERICA CORP.
LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
1996-02-21
KANEKA PHARMA AMERICA CORP.

PMN#

SurfRider 13 Microcatheter
2026-01-05
Kaneka Americas Holding, Inc.
Thrombuster II Aspiration Catheter
2021-10-26
Kaneka Medical America, LLC
I-ED COIL System
2021-03-26
Kaneka Medical America LLC
I-ED COIL
2020-04-25
Kaneka Pharma America LLC
OTW Takeru PTCA Balloon Dilatation Catheter
2018-03-19
Kaneka Corporation
RX NC Takeru PTCA Balloon Dilatation Catheter
2017-07-07
Kaneka Corporation
Lacriflow CL
2017-04-18
KANEKA PHARMA AMERICA LLC
RX Takeru Balloon Dilatation Catheter
2017-04-07
KANEKA CORPORATION
R2P Metacross RX
2017-01-11
KANEKA CORPORATION
Crosstella OTW
2016-04-29
KANEKA CORPORATION
Crosperio OTW
2016-04-29
KANEKA CORPORATION
Crosperio RX PTA Balloon Dilatation Catheter
2016-01-22
Kaneka Corporation
Crosstella RX Balloon Dilatation Catheter
2016-01-22
KANEKA CORPORATION
Metacross OTW PTA Balloon Dilatation Catheter
2015-09-24
Kaneka Corporation
Metacross RX PTA Balloon Dilitation Catheter
2015-08-03
Kaneka Corporation
XPRESSWAY RX CATHETER (6F LD-VERISON)
2012-07-30
KANEKA PHARMA AMERICA LLC
TRIMOTION INJECTOR
2011-12-29
KANEKA CORP.
KANEKA PHARMA AMERICA XPRESS-WAY RX
2010-10-22
KANEKA PHARMA AMERICA LLC

GUDID#

LIXELLE - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2024-10-25
LIXELLE - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2024-10-25
LIXELLE - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2024-10-25
LIPOSORBER - Indications for FH:The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.Indications for FSGS:The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA CORPORATION
2014-09-26
i-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.
KANEKA CORPORATION
2025-12-10
i-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.
KANEKA CORPORATION
2025-12-10
i-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.
KANEKA CORPORATION
2025-12-10
i-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.
KANEKA CORPORATION
2025-12-10
LACRIFLOW CL - The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of:- Canalicular pathologies (stenosis, obstruction, lacerations),- During Dacryocystorhinostomy (conventional or laser),- Congenital nasolacrimal duct obstruction.
KANEKA CORPORATION
2017-06-01
LACRIFLOW CL - The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of:- Canalicular pathologies (stenosis, obstruction, lacerations),- During Dacryocystorhinostomy (conventional or laser),- Congenital nasolacrimal duct obstruction.
KANEKA CORPORATION
2017-06-01
i-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.
KANEKA CORPORATION
2025-06-26
Lixelle - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2015-05-01
Lixelle - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2015-05-01
Lixelle - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2015-05-01
i-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.
KANEKA CORPORATION
2024-10-25
i-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.
KANEKA CORPORATION
2024-10-25
i-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.
KANEKA CORPORATION
2024-10-25
LIXELLE - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2024-10-25
LIXELLE - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2024-10-25
LIXELLE - The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
2024-10-25
i-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.
KANEKA CORPORATION
2023-07-27
i-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.
KANEKA CORPORATION
2022-05-30
i-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.
KANEKA CORPORATION
2022-05-30
i-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.
KANEKA CORPORATION
2022-05-24
i-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.
KANEKA CORPORATION
2022-05-24
i-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.
KANEKA CORPORATION
2022-05-24
i-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.
KANEKA CORPORATION
2022-05-24
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30
i-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.
KANEKA CORPORATION
2020-06-30

200 records. Showing 1-40. Next