FDA applicant
Bausch and Lomb, Incorporated
FDA records 7 decisions for Bausch and Lomb, Incorporated (St. Louis, MO) from 2016 to 2026: 6 510(k) clearances and 1 original PMA approval. Most are in product codes HQC (Unit, Phacofragmentation) and MRC (Products, Contact Lens Care, Rigid Gas Permeable). Since 2016 its 510(k)s took a median of 186 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bausch and Lomb”, “Bausch and Lomb, Inc.,”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bausch and Lomb, Incorporated’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Bausch and Lomb, Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Bausch”
FDA records each applicant name separately; these may or may not be the same firm.