Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1018706057
Device Listing 1018706057
Listing Summary
#
Listing key
1018706057
Premarket submission
K243444
Device
BIOCERAM AZULĀ® HEAD
Applicant
Kyocera Corporation
Product code
LZO
Decision date
2024-12-05
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
67855
3006536454
3006536454
KYOCERA Medical Corporation Shiga Higashiomi Plant
1
N
2026-01-01
10-1 KAWAI-CHO Higashiomi-shi Shiga JP 529-1571
203626
3012119238
3012119238
Cheryl Hastings
1
N
2026-01-01
2256 E Blossom Lane Warsaw IN US 46580
203577
3012425419
3010566635
KYOCERA Medical Corporation
1
N
2026-01-01
6 Takeda Tobadono-cho, Fushimi-ku Kyoto JP 612-8450