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KYOCERA Medical Corporation Shiga Yasu Plant: FDA-registered device maker in Yasu-shi Shiga, Japan, 2 510(k) clearances

Name: KYOCERA Medical Corporation Shiga Yasu Plant FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

KYOCERA Medical Corporation Shiga Yasu Plant is registered with the FDA (registration 3012119238) in Yasu-shi Shiga, Japan. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 5, 2024. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3012119238
Address: 800 Ichimiyake, Yasu-shi Shiga, Japan, 520-2362
Owner or operator: KYOCERA Medical Corporation (9097359)
Roles: Contract manufacturer, Manufacturer
First device listed: February 18, 2010
Registered through: 2027
Brand names listed: AFFINITY CP CENTRIFUGAL BLOOD PUMP, Affinity CP Pump with Balance Coating, Affinity CP Pump with Carmeda Coating, DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads, DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads, DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads

Devices it lists

Device	Product code	Class	Role	Source
Control, Pump Speed, Cardiopulmonary Bypass	DWA	2	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	JDL	3	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	KWA	3	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Manufacturer	accessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	KFM	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 5, 2024	K243444	BIOCERAM AZUL® HEAD	LZO	Substantially Equivalent	Kyocera Corporation	accessdata.fda.gov
November 1, 2016	K160895	Initia Total Hip System & BIOCERAM AZUL(R) HEAD	LZO	Substantially Equivalent	Kyocera Medical Corporation	accessdata.fda.gov

Compare with other makers

Updated December 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.