Mesoblast: FDA clearances and approvals
Mesoblast has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov. It files with the SEC as MESOBLAST LTD (MEOBF, MESO).
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular | 1 | 0 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170016 | PMA | SYNOJOYNT | 2018-05-08 |
Recalls
openFDA lists no recalls under a recalling firm named Mesoblast.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Mesoblast is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01106417: Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion (Completed, started 2010-06)
SEC filings
MESOBLAST LTD (MEOBF, MESO): EDGAR filings, CIK 1345099. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Mesoblast have?
Mesoblast has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Mesoblast make?
Its most frequent FDA product codes are MOZ (Acid, Hyaluronic, Intraarticular, 1).
Has Mesoblast had device recalls?
openFDA lists no recalls under a recalling firm name matching Mesoblast. Related entities may recall under other names.
Next steps
- See all 0 Mesoblast clearances with predicates and recalls
- Run predicate analysis for product code MOZ, Mesoblast's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.