Kyocera Corp

FDA Filings

This page includes the latest FDA filings for Kyocera Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012425419
• FEI Number: 3010566635
• Name: KYOCERA CORPORATION
• Owner & Operator: KYOCERA Corporation
• Contact Address: 3-3-31 Miyahara, Yodogawa-ku --; Osaka JP-NOTA 532-0003 JP
• Official Correspondent:
  • Masato - Atsumi
  • 81-6-71757702-x
• US Agent:
  • Cheryl Hastings
  • Hastings Regulatory Consulting, LLC
  • 574 5274220
  • Cheryl-Hastings@comcast.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3-3-31 Miyahara, Yodogawa-ku ; Osaka Osaka, 532-0003 JP
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3006536454
• FEI Number: 3006536454
• Name: KYOCERA Corporation Shiga Gamo Plant
• Owner & Operator: KYOCERA Corporation
• Contact Address: 3-3-31 Miyahara, Yodogawa-ku --; Osaka JP-NOTA 532-0003 JP
• Official Correspondent:
  • Masato - Atsumi
  • 81-6-71757702-x
• US Agent:
  • Cheryl Hastings
  • Hastings Regulatory Consulting, LLC
  • 574 5274220
  • Cheryl-Hastings@comcast.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10-1 KAWAI-CHO Higashiomi-shi; Shiga Siga, 529-1595 JP
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

• Registration Number: 3012119238
• FEI Number: 3012119238
• Name: Cheryl Hastings
• Owner & Operator: KYOCERA Corporation
• Contact Address: 3-3-31 Miyahara, Yodogawa-ku --; Osaka JP-NOTA 532-0003 JP
• Official Correspondent:
  • Masato - Atsumi
  • 81-6-71757702-x
• US Agent:
  • Cheryl Hastings
  • Hastings Regulatory Consulting, LLC
  • 574 5274220
  • Cheryl-Hastings@comcast.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2256 E Blossom Lane ; Warsaw, IN 46580 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 04547898777585 KYOCERA CORPORATION	Initia Total Hip System TJ51146-3	2023-06-01
GUDID 04547898777578 KYOCERA CORPORATION	Initia Total Hip System TJ51146-2	2023-06-01
GUDID 04547898777561 KYOCERA CORPORATION	Initia Total Hip System TJ51146-1	2023-06-01
GUDID 04547898440434 KYOCERA CORPORATION	Initia Total Hip System TJ51461	2022-12-14
GUDID 04547898439049 KYOCERA CORPORATION	Initia Total Hip System TJ51146-3	2022-12-14
GUDID 04547898439032 KYOCERA CORPORATION	Initia Total Hip System TJ51146-2	2022-12-14
GUDID 04547898439025 KYOCERA CORPORATION	Initia Total Hip System TJ51146-1	2022-12-14
GUDID 04547898438974 KYOCERA CORPORATION	Initia Total Hip System TJ51147	2022-12-14
GUDID 04547898438233 KYOCERA CORPORATION	Initia Total Hip System TJ51247	2022-11-17
GUDID 04547898438080 KYOCERA CORPORATION	Initia Total Hip System TJ42890	2022-11-17
GUDID 04547898433979 KYOCERA CORPORATION	Initia Total Hip System 21057-00-0000	2021-12-08
GUDID 04547898432538 KYOCERA CORPORATION	Initia Total Hip System TJ39647-1	2021-12-08
GUDID 04547898432521 KYOCERA CORPORATION	Initia Total Hip System TJ39645-1	2021-12-08
GUDID 04547898432514 KYOCERA CORPORATION	Initia Total Hip System TJ39643-1	2021-12-08
GUDID 04547898432507 KYOCERA CORPORATION	Initia Total Hip System TJ39641-1	2021-12-08
GUDID 04547898432491 KYOCERA CORPORATION	Initia Total Hip System TJ39639-1	2021-12-08
GUDID 04547898305542 KYOCERA CORPORATION	Initia Total Hip System GMH02-100016	2019-03-18
GUDID 04547898305535 KYOCERA CORPORATION	Initia Total Hip System GMH02-100015	2019-03-18
GUDID 04547898305528 KYOCERA CORPORATION	Initia Total Hip System GMH02-100014	2019-03-18
GUDID 04547898305511 KYOCERA CORPORATION	Initia Total Hip System GMH02-100013	2019-03-18
GUDID 04547898305504 KYOCERA CORPORATION	Initia Total Hip System GMH02-100012	2019-03-18
GUDID 04547898305498 KYOCERA CORPORATION	Initia Total Hip System GMH02-100011	2019-03-18
GUDID 04547898305481 KYOCERA CORPORATION	Initia Total Hip System GMH02-100010	2019-03-18
GUDID 04547898305474 KYOCERA CORPORATION	Initia Total Hip System GMH02-100009	2019-03-18
GUDID 04547898305467 KYOCERA CORPORATION	Initia Total Hip System GMH02-100008	2019-03-18
GUDID 04547898305450 KYOCERA CORPORATION	Initia Total Hip System GMH02-100007	2019-03-18
GUDID 04547898305443 KYOCERA CORPORATION	Initia Total Hip System GMH02-100006	2019-03-18
GUDID 04547898305436 KYOCERA CORPORATION	Initia Total Hip System GMH02-100005	2019-03-18
GUDID 04547898305429 KYOCERA CORPORATION	Initia Total Hip System GMH02-100004	2019-03-18
GUDID 04547898305412 KYOCERA CORPORATION	Initia Total Hip System GMH02-100003	2019-03-18
GUDID 04547898305405 KYOCERA CORPORATION	Initia Total Hip System GMH02-100002	2019-03-18
GUDID 04547898305399 KYOCERA CORPORATION	Initia Total Hip System GMH02-100001	2019-03-18
GUDID 04547898305382 KYOCERA CORPORATION	Initia Total Hip System GMH03-400030	2019-03-18
GUDID 04547898305375 KYOCERA CORPORATION	Initia Total Hip System GMH03-400029	2019-03-18
GUDID 04547898305368 KYOCERA CORPORATION	Initia Total Hip System GMH03-400028	2019-03-18
GUDID 04547898305351 KYOCERA CORPORATION	Initia Total Hip System GMH03-400027	2019-03-18
GUDID 04547898305344 KYOCERA CORPORATION	Initia Total Hip System GMH03-400026	2019-03-18
GUDID 04547898305337 KYOCERA CORPORATION	Initia Total Hip System GMH03-400025	2019-03-18
GUDID 04547898305320 KYOCERA CORPORATION	Initia Total Hip System GMH03-400024	2019-03-18
GUDID 04547898305313 KYOCERA CORPORATION	Initia Total Hip System GMH03-400023	2019-03-18
GUDID 04547898305306 KYOCERA CORPORATION	Initia Total Hip System GMH03-400022	2019-03-18
GUDID 04547898305290 KYOCERA CORPORATION	Initia Total Hip System GMH03-400021	2019-03-18
GUDID 04547898305283 KYOCERA CORPORATION	Initia Total Hip System GMH03-400020	2019-03-18
GUDID 04547898305276 KYOCERA CORPORATION	Initia Total Hip System GMH03-400019	2019-03-18
GUDID 04547898305269 KYOCERA CORPORATION	Initia Total Hip System GMH03-400018	2019-03-18
GUDID 04547898305252 KYOCERA CORPORATION	Initia Total Hip System GMH03-400017	2019-03-18
GUDID 04547898305245 KYOCERA CORPORATION	Initia Total Hip System GMH03-400016	2019-03-18
GUDID 04547898305238 KYOCERA CORPORATION	Initia Total Hip System GMH03-400015	2019-03-18
GUDID 04547898305221 KYOCERA CORPORATION	Initia Total Hip System GMH03-400014	2019-03-18
GUDID 04547898305214 KYOCERA CORPORATION	Initia Total Hip System GMH03-400013	2019-03-18
GUDID 04547898305207 KYOCERA CORPORATION	Initia Total Hip System GMH03-400012	2019-03-18
GUDID 04547898305191 KYOCERA CORPORATION	Initia Total Hip System GMH03-400011	2019-03-18
GUDID 04547898305184 KYOCERA CORPORATION	Initia Total Hip System GMH03-400010	2019-03-18
GUDID 04547898305177 KYOCERA CORPORATION	Initia Total Hip System GMH03-400009	2019-03-18
GUDID 04547898305160 KYOCERA CORPORATION	Initia Total Hip System GMH03-400008	2019-03-18
GUDID 04547898305153 KYOCERA CORPORATION	Initia Total Hip System GMH03-400007	2019-03-18
GUDID 04547898305146 KYOCERA CORPORATION	Initia Total Hip System GMH03-400006	2019-03-18
GUDID 04547898305139 KYOCERA CORPORATION	Initia Total Hip System GMH03-400005	2019-03-18
GUDID 04547898305122 KYOCERA CORPORATION	Initia Total Hip System GMH03-400004	2019-03-18
GUDID 04547898305115 KYOCERA CORPORATION	Initia Total Hip System GMH03-400003	2019-03-18
GUDID 04547898305108 KYOCERA CORPORATION	Initia Total Hip System GMH03-400002	2019-03-18
GUDID 04547898305092 KYOCERA CORPORATION	Initia Total Hip System GMH03-400001	2019-03-18
GUDID 04547898305085 KYOCERA CORPORATION	Initia Total Hip System GMH02-500048	2019-03-18
GUDID 04547898305078 KYOCERA CORPORATION	Initia Total Hip System GMH02-500047	2019-03-18
GUDID 04547898305061 KYOCERA CORPORATION	Initia Total Hip System GMH02-500046	2019-03-18
GUDID 04547898305054 KYOCERA CORPORATION	Initia Total Hip System GMH02-500045	2019-03-18
GUDID 04547898305047 KYOCERA CORPORATION	Initia Total Hip System GMH02-500044	2019-03-18
GUDID 04547898305030 KYOCERA CORPORATION	Initia Total Hip System GMH02-500043	2019-03-18
GUDID 04547898305023 KYOCERA CORPORATION	Initia Total Hip System GMH02-500042	2019-03-18
GUDID 04547898305016 KYOCERA CORPORATION	Initia Total Hip System GMH02-500041	2019-03-18
GUDID 04547898305009 KYOCERA CORPORATION	Initia Total Hip System GMH02-500040	2019-03-18
GUDID 04547898304996 KYOCERA CORPORATION	Initia Total Hip System GMH02-500039	2019-03-18
GUDID 04547898304989 KYOCERA CORPORATION	Initia Total Hip System GMH02-500038	2019-03-18
GUDID 04547898304972 KYOCERA CORPORATION	Initia Total Hip System GMH02-500037	2019-03-18
GUDID 04547898304965 KYOCERA CORPORATION	Initia Total Hip System GMH02-500036	2019-03-18
GUDID 04547898304958 KYOCERA CORPORATION	Initia Total Hip System GMH02-500035	2019-03-18
GUDID 04547898304941 KYOCERA CORPORATION	Initia Total Hip System GMH02-500034	2019-03-18
GUDID 04547898304934 KYOCERA CORPORATION	Initia Total Hip System GMH02-500033	2019-03-18
GUDID 04547898304927 KYOCERA CORPORATION	Initia Total Hip System GMH02-500032	2019-03-18
GUDID 04547898304910 KYOCERA CORPORATION	Initia Total Hip System GMH02-500031	2019-03-18
GUDID 04547898304903 KYOCERA CORPORATION	Initia Total Hip System GMH02-500030	2019-03-18
GUDID 04547898304897 KYOCERA CORPORATION	Initia Total Hip System GMH02-500029	2019-03-18
GUDID 04547898304880 KYOCERA CORPORATION	Initia Total Hip System GMH02-500028	2019-03-18
GUDID 04547898304873 KYOCERA CORPORATION	Initia Total Hip System GMH02-500027	2019-03-18
GUDID 04547898304866 KYOCERA CORPORATION	Initia Total Hip System GMH02-500026	2019-03-18
GUDID 04547898304859 KYOCERA CORPORATION	Initia Total Hip System GMH02-500025	2019-03-18
GUDID 04547898304842 KYOCERA CORPORATION	Initia Total Hip System GMH02-500024	2019-03-18
GUDID 04547898304835 KYOCERA CORPORATION	Initia Total Hip System GMH02-500023	2019-03-18
GUDID 04547898304828 KYOCERA CORPORATION	Initia Total Hip System GMH02-500022	2019-03-18
GUDID 04547898304811 KYOCERA CORPORATION	Initia Total Hip System GMH02-500021	2019-03-18
GUDID 04547898304804 KYOCERA CORPORATION	Initia Total Hip System GMH02-500020	2019-03-18
GUDID 04547898304798 KYOCERA CORPORATION	Initia Total Hip System GMH02-500019	2019-03-18
GUDID 04547898304781 KYOCERA CORPORATION	Initia Total Hip System GMH02-500018	2019-03-18
GUDID 04547898304774 KYOCERA CORPORATION	Initia Total Hip System GMH02-500017	2019-03-18
GUDID 04547898304767 KYOCERA CORPORATION	Initia Total Hip System GMH02-500016	2019-03-18
GUDID 04547898304750 KYOCERA CORPORATION	Initia Total Hip System GMH02-500015	2019-03-18
GUDID 04547898304743 KYOCERA CORPORATION	Initia Total Hip System GMH02-500014	2019-03-18
GUDID 04547898304736 KYOCERA CORPORATION	Initia Total Hip System GMH02-500013	2019-03-18
GUDID 04547898304729 KYOCERA CORPORATION	Initia Total Hip System GMH02-500012	2019-03-18
GUDID 04547898304712 KYOCERA CORPORATION	Initia Total Hip System GMH02-500011	2019-03-18
PMN K111658 | KFM Cheryl Hastings [KYOCERA Corporation]	Affinity CP Pump with Carmeda Coating	2013-01-07
PMN K111657 | KFM Cheryl Hastings [KYOCERA Corporation]	Affinity CP Pump with Balance Coating	2013-01-07
PMN K082924 | KWA KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads	2011-05-24
PMN K082924 | KWA Cheryl Hastings [KYOCERA Corporation]	DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads	2011-05-24
PMN K082924 | JDL KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads	2011-05-24
PMN K082924 | JDL Cheryl Hastings [KYOCERA Corporation]	DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads	2011-05-24
PMN K100008 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	CARDO MEDICAL CERAMIC HIP SYSTEM 32mm and 36mm Alumina Ceramic Femoral Heads	2011-05-09
PMN K100631 | KFM Cheryl Hastings [KYOCERA Corporation]	AFFINITY CP CENTRIFUGAL BLOOD PUMP	2010-07-28
PMN K100631 | DWA Cheryl Hastings [KYOCERA Corporation]	AFFINITY CP CENTRIFUGAL BLOOD PUMP	2010-07-28
PMN K072656 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads	2010-02-18
PMN K072656 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads	2010-02-18
PMN K072656 | LZO Cheryl Hastings [KYOCERA Corporation]	DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads	2010-02-18
PMN K072656 | LZO Cheryl Hastings [KYOCERA Corporation]	DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads	2010-02-18
PMN K920290 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 32MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K920219 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 26MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K915310 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K915309 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL	2007-02-01
PMN K894904 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	KINAMED CERAMIC ATH TOTAL HIP -28MM BALL	2007-02-01
PMN K890472 | LZO KYOCERA Corporation Shiga Gamo Plant [KYOCERA Corporation]	ATH CERAMIC UHMWPE TOTAL HIP SYSTEM KINAMED 32MM BIOCERAM-Z TOTAL HIP BALL	2007-02-01

Similar & Related FDA Registered Companies

• KYOCERA Medical Corporation

Related Finance Registrations

NCAGE Code	0P8E8	KYOCERA CORP
NCAGE Code	SS615	KYOCERA CORP.
NCAGE Code	S7973	KYOCERA CORPORATION
NCAGE Code	S7506	KYOCERA CORPORATION
CAGE Code	0P8E8	KYOCERA CORP
CAGE Code	S7506	KYOCERA CORPORATION
CAGE Code	S7973	KYOCERA CORPORATION
CAGE Code	SS615	KYOCERA CORP.
SEC	0000057083	KYOCERA CORP

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092529945	Kobe,Japan -> Oakland, California	SILICON NITRIDE POWDER (3824.99)	2 CTN
2020092527417	Kobe,Japan -> Oakland, California	ISOLATOR BLANK (6909.12)	4 CTN
2020092546755	Kobe,Japan -> Los Angeles, California	TELEPHONE FOR CELLULAR NETWORKS, WIRELESS NE	682 CTN
2020092546511	Kobe,Japan -> Los Angeles, California	CERAMIC KNIFE (6912.00)	160 CTN
2020092527414	Kobe,Japan -> Oakland, California	SN IGNITER (8516.80)	59 CTN
2020092436928	Kobe,Japan -> Los Angeles, California	TELEPHONE FOR CELLULAR NETWORKS, WIRELESS NE	560 CTN
2020092251405	Kobe,Japan -> Los Angeles, California	TELEPHONE FOR CELLULAR NETWORKS, WIRELESS NE	560 CTN
2020091950693	Kobe,Japan -> Los Angeles, California	TELEPHONE FOR CELLULAR NETWORKS, WIRELESS NE	560 CTN