Bausch & Lomb Pharmaceutical, Inc.: FDA clearances and approvals
Bausch & Lomb Pharmaceutical, Inc. has 6 FDA 510(k) clearances (first 1988, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time: 64 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOE | Collagen Corneal Shield | 5 | 5 |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Bausch & Lomb Pharmaceutical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | MOE | 1990-02-09 | 448 |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | MOE | 1989-02-13 | 87 |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | MOE | 1989-02-13 | 87 |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | MOE | 1988-11-29 | 40 |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | MOE | 1988-11-29 | 40 |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | HQJ | 1988-11-29 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Bausch & Lomb Pharmaceutical, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Bausch & Lomb Pharmaceutical, Inc. have?
Bausch & Lomb Pharmaceutical, Inc. has 6 FDA 510(k) clearances (first 1988, latest 1990), across 2 product codes in 1 review panel.
How long does FDA take to clear Bausch & Lomb Pharmaceutical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bausch & Lomb Pharmaceutical, Inc.'s cleared 510(k)s is 64 days.
What devices does Bausch & Lomb Pharmaceutical, Inc. make?
Its most frequent FDA product codes are MOE (Collagen Corneal Shield, 5); HQJ (Implant, Absorbable, (Scleral Buckling Methods), 1).
Has Bausch & Lomb Pharmaceutical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bausch & Lomb Pharmaceutical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Bausch & Lomb Pharmaceutical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOE, Bausch & Lomb Pharmaceutical, Inc.'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.