Bausch Health Companies, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Bausch Health Companies, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZP | Aid, Surgical, Viscoelastic | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220009 | PMA | StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) | 2023-02-22 |
Recalls
openFDA lists no recalls under a recalling firm named Bausch Health Companies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Bausch Health Companies Inc. (BHC): EDGAR filings, CIK 885590. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bausch & Lomb, Inc. (102 510(k)s)
- Bausch & Lomb, Incorporated (23 510(k)s)
- Bausch & Lomb Pharmaceutical, Inc. (6 510(k)s)
- Bausch + Lomb, Incorporated (4 510(k)s)
- Bausch and Lomb (3 510(k)s)
- Bausch and Lomb, Incorporated (3 510(k)s)
- Bausch Health Americas Incorporated (1 510(k)s)
- Bausch & Lomb Healthcare and Optics Worldwide (1 510(k)s)
- Bausch Health (0 510(k)s)
- Bausch + Lomb Ireland Limited (0 510(k)s)
- Bausch & Lomb Surgical, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bausch Health Companies, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Bausch Health Companies, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Bausch Health Companies, Inc.?
The most frequent FDA product codes under this applicant name are LZP (Aid, Surgical, Viscoelastic, 1).
Next steps
- See all 0 Bausch Health Companies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZP, Bausch Health Companies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.