Bausch + Lomb Ireland Limited: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Bausch + Lomb Ireland Limited”, 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 |
|---|---|---|---|
| MVF | System, Laser, Photodynamic Therapy | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050026 | PMA | QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS | 2006-04-04 |
Recalls
openFDA lists no recalls under a recalling firm named Bausch + Lomb Ireland Limited.
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 Surgical, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bausch + Lomb Ireland Limited?
FDA lists 0 510(k) clearances under the applicant name “Bausch + Lomb Ireland Limited”, 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 Ireland Limited?
The most frequent FDA product codes under this applicant name are MVF (System, Laser, Photodynamic Therapy, 1).
Next steps
- See all 0 Bausch + Lomb Ireland Limited clearances with predicates and recalls
- Run predicate analysis for product code MVF, Bausch + Lomb Ireland Limited'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.