Bausch & Lomb Surgical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Bausch & Lomb Surgical, 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.
Caduvo groups this applicant name under Bausch + Lomb, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQL | Intraocular Lens | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850059 | PMA | KELMAN(TM) OMNIFIT II MODEL 2100 | 1986-07-31 |
Recalls
11 product recalls in 9 recall events; 3 initiated in the last five years. Most recent: 2025-06-06.
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.
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 Health Companies, Inc. (0 510(k)s)
- Bausch + Lomb Ireland Limited (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bausch & Lomb Surgical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Bausch & Lomb Surgical, 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 & Lomb Surgical, Inc.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 1).
Next steps
- See all 0 Bausch & Lomb Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Bausch & Lomb Surgical, 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.