This page includes the latest FDA filings for Kaneka Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| JAPAN | TOKYO STOCK EXCHANGE | 4118 | DUNS 690535406 |
| 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 |
| Registration Number | 3009761573 |
| FEI Number | 3009761573 |
| Name | KANEKA MEDIX CORPORATION KANAGAWA PLANT |
| Owner & Operator | KANEKA CORP. |
| Contact Address | 2-3-18, Nakanoshima, Kita-ku Osaka JP-27 Osaka 530-8288 JP |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 225-1 Aza Deguchi, Yamakita Yamakita-machi Ashigara-Kami-gun Kanagawa, 2580113 JP |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 9614654 |
| FEI Number | 3002808904 |
| Name | Kazuhiko Inoue |
| Owner & Operator | KANEKA CORP. |
| Contact Address | 2-3-18, Nakanoshima, Kita-ku Osaka JP-27 Osaka 530-8288 JP |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 546 FIFTH AVENUE 21 ST FL NEW YORK, NY 10036 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| KANEKA CORPORATION | i-ED COIL 390-01H4 | 2023-08-04 |
| KANEKA CORPORATION | i-ED COIL 393-020304 | 2022-06-07 |
| KANEKA CORPORATION | i-ED COIL 390-0101 | 2022-06-07 |
| KANEKA CORPORATION | i-ED COIL 372-041030 | 2022-06-01 |
| KANEKA CORPORATION | i-ED COIL 372-041020 | 2022-06-01 |
| KANEKA CORPORATION | i-ED COIL 371-041015 | 2022-06-01 |
| KANEKA CORPORATION | i-ED COIL 371-041010 | 2022-06-01 |
| KANEKA CORPORATION | EDG v4 347-404U | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 374-142450 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 373-122050 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 373-051250 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 373-051230 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 373-040830 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 373-040815 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 373-040810 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 393-030520 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 393-030515 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 393-020310 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 393-020306 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-1650 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-1450 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-1250 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-1040 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0940 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0840 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0730 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0620 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0515 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0510 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0410 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-03H8 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0306 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 392-0304 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0308 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0306 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0304 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-02H6 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-02H4 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0208 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0206 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0204 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0203 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-01H3 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-01H2 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0103 | 2020-07-08 |
| KANEKA CORPORATION | i-ED COIL 390-0102 | 2020-07-08 |
| KANEKA CORPORATION | LACRIFLOW CL | 2019-12-11 |
| KANEKA CORPORATION | LACRIFLOW CL | 2019-12-11 |
| KANEKA CORPORATION | LACRIFLOW | 2019-12-11 |
| KANEKA CORPORATION | LACRIFLOW | 2019-12-11 |
| KANEKA CORPORATION | RX TAKERU DC-RY2020UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY1520UA1 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY5015UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4515UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4015UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3715UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3515UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3215UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3015UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2715UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2515UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2215UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2015UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY1515UA1 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY5012UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4512UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4012UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3712UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3512UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3212UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3012UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2712UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2512UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2212UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2012UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY1512UA1 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4010UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3510UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3010UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2510UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2010UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY1510UA1 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY5008UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4508UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY4008UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3708UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3508UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3208UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3008UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2708UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2508UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2208UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2008UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY1508UA1 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY3006UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2706UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2506UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2206UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY2006UA2 | 2019-10-07 |
| KANEKA CORPORATION | RX TAKERU DC-RY1506UA1 | 2019-10-07 |
Kazuhiko Inoue [KANEKA CORP.] | Liposorber LA-15 System | 2018-03-23 |
Kaneka Corporation | OTW Takeru PTCA Balloon Dilatation Catheter | 2018-03-19 |
Kazuhiko Inoue [KANEKA CORP.] | OTW Takeru | 2018-03-19 |
Kazuhiko Inoue [KANEKA CORP.] | RX NC Takeru | 2017-07-09 |
Kaneka Corporation | RX NC Takeru PTCA Balloon Dilatation Catheter | 2017-07-07 |
KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.] | Lacriflow CL | 2017-04-19 |
Kazuhiko Inoue [KANEKA CORP.] | RX Takeru | 2017-04-09 |
KANEKA CORPORATION | RX Takeru Balloon Dilatation Catheter | 2017-04-07 |
KANEKA CORPORATION | R2P Metacross RX | 2017-01-11 |
Kazuhiko Inoue [KANEKA CORP.] | R2P Metacross RX | 2017-01-11 |
Kazuhiko Inoue [KANEKA CORP.] | Crosperio OTW | 2016-05-01 |
Kazuhiko Inoue [KANEKA CORP.] | Crosstella OTW | 2016-05-01 |
KANEKA CORPORATION | Crosperio OTW | 2016-04-29 |
KANEKA CORPORATION | Crosstella OTW | 2016-04-29 |
Kazuhiko Inoue [KANEKA CORP.] | Crosperio RX | 2016-01-25 |
Kazuhiko Inoue [KANEKA CORP.] | R2P Crosstella RX | 2016-01-25 |
Kazuhiko Inoue [KANEKA CORP.] | Crosstella RX | 2016-01-25 |
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 |
Kazuhiko Inoue [KANEKA CORP.] | Metacross OTW | 2015-09-24 |
Kazuhiko Inoue [KANEKA CORP.] | Metacross RX | 2015-08-06 |
Kaneka Corporation | Metacross RX PTA Balloon Dilitation Catheter | 2015-08-03 |
Kazuhiko Inoue [KANEKA CORP.] | Lixelle ?2-microglobulin Apheresis Column | 2015-03-31 |
Kazuhiko Inoue [KANEKA CORP.] | Liposorber LA-15 System | 2013-11-01 |
KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.] | LACRIFLOW | 2013-04-05 |
KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.] | Xpress-Way RX (LD) | 2012-08-19 |
KANEKA CORP. | TRIMOTION INJECTOR | 2011-12-29 |
KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.] | Xpress-Way RX | 2010-10-27 |
Kazuhiko Inoue [KANEKA CORP.] | Liposorber LA-15 system | 2007-10-16 |
| NCAGE Code | SEDH9 | KANEKA CORPORATION |
| CAGE Code | SEDH9 | KANEKA CORPORATION |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020092667383 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK37 H.S.CODE 3904.10 INVOICE NO. TS08-03 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667383 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK37 H.S.CODE 3904.10 INVOICE NO. TS08-03 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667383 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK37 H.S.CODE 3904.10 INVOICE NO. TS08-03 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667383 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK37 H.S.CODE 3904.10 INVOICE NO. TS08-03 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667381 | Puerto Manzanillo,Panama -> Houston, Texas | 80 FLECON BAGS | 80 PCS |
| 2020092667381 | Puerto Manzanillo,Panama -> Houston, Texas | 80 FLECON BAGS | 80 PCS |
| 2020092667381 | Puerto Manzanillo,Panama -> Houston, Texas | 80 FLECON BAGS | 80 PCS |
| 2020092667381 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK36 H.S.CODE 3904.10 INVOICE NO. TS08-01 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667382 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK36 H.S.CODE 3904.10 INVOICE NO. TS08-02 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667382 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK36 H.S.CODE 3904.10 INVOICE NO. TS08-02 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667382 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK36 H.S.CODE 3904.10 INVOICE NO. TS08-02 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092667382 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN GRADE SCK36 H.S.CODE 3904.10 INVOICE NO. TS08-02 DDC PREPAID "FREIGHT PREPAID" "AS ARRANGED" 80 PALLETS | 80 PCS |
| 2020092556670 | Tokyo ,Japan -> Los Angeles, California | KANEKA PVC RESIN | 900 BAG |
| 2020092544782 | Kobe,Japan -> Los Angeles, California | SYNTHETIC FIBER HAIR GOODS HS CODE : 5501.30 | 55 CTN |
| 2020091859365 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN 66 PALLETS (66 FLECON BAGS) KANEKA PVC RESIN GRADE KS-2500 NET WEIGHT 52,800 KGS H.S.CODE 3904.10 | 66 PCS |
| 2020091859365 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN 66 PALLETS (66 FLECON BAGS) KANEKA PVC RESIN GRADE KS-2500 NET WEIGHT 52,800 KGS H.S.CODE 3904.10 | 66 PCS |
| 2020091859365 | Puerto Manzanillo,Panama -> Houston, Texas | KANEKA PVC RESIN 66 PALLETS (66 FLECON BAGS) KANEKA PVC RESIN GRADE KS-2500 NET WEIGHT 52,800 KGS H.S.CODE 3904.10 | 66 PCS |
| 2020091852775 | Kobe,Japan -> Los Angeles, California | KANEKA SILYL(RESIN) HS CODE: 3907.20 | 10 DRM |
| 2020091161990 | Kobe,Japan -> Los Angeles, California | FILAMENT TOW OF ACRYLIC OR MODACRYLIC | 155 CTN |