Kyocera Corporation · 89-08 · JAPAN
For Kyocera Corporation · 89-08 · JAPAN, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is JAPAN; product code is 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented; date published is 09/16/2009; address is 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN, verified against its source on 2026-09-16.
- Firm
- Kyocera Corporation verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- JAPAN verified
- Address
- 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN verified
- Date published
- 09/16/2009 verified
- Product code
- 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented verified
- FDA notes
- Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005 verified
What the source says
Kyocera Corporation Date Published : 09/16/2009 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Date Published: 09/16/2009 Notes: Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.