Company ยท KR
Maruchi
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2023. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2023 | K213757 | Endocem MTA Premixed Regular Maruchi, KR | KIF |
| Aug 13, 2021 | K212229 | White Endoseal MTA Maruchi, KR | KIF |
| Mar 24, 2021 | K202015 | White ENDOSEAL MTA Maruchi, KR | KIF |
| Feb 12, 2021 | K201799 | CleaniCal Maruchi, KR | EJK |
| Feb 26, 2018 | K170175 | ENDOSEAL MTA Maruchi, KR | KIF |
| May 12, 2014 | K133054 | ENDOSEAL Maruchi | KIF |
| May 12, 2014 | K133042 | ENDOCEM ZR Maruchi | KIF |
| Mar 19, 2012 | K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) Maruchi | KIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||