Ibsa Institut Biochimique SA: FDA clearances and approvals
Ibsa Institut Biochimique SA 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 2 device clinical trials on ClinicalTrials.gov.
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 |
|---|---|---|---|
| P110005 | PMA | SINOVIAL (SODIUM HYALURONATE 0.8%) | 2014-05-09 |
Recalls
openFDA lists no recalls under a recalling firm named Ibsa Institut Biochimique SA.
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
Ibsa Institut Biochimique SA is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03200288: A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis (Completed, started 2017-06-29)
- NCT00556608: Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis (Completed, started 2007-11)
Frequently asked questions
How many FDA 510(k) clearances does Ibsa Institut Biochimique SA have?
Ibsa Institut Biochimique SA has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Ibsa Institut Biochimique SA make?
Its most frequent FDA product codes are MOZ (Acid, Hyaluronic, Intraarticular, 1).
Has Ibsa Institut Biochimique SA had device recalls?
openFDA lists no recalls under a recalling firm name matching Ibsa Institut Biochimique SA. Related entities may recall under other names.
Next steps
- See all 0 Ibsa Institut Biochimique SA clearances with predicates and recalls
- Run predicate analysis for product code MOZ, Ibsa Institut Biochimique SA'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.