FDA applicant
Meridian AG
FDA records 14 decisions for Meridian AG (Thun, CH) from 1986 to 2024: 13 510(k) clearances and 1 original PMA approval. Most are in product codes HQF (Laser, Ophthalmic) and GZO (Device, Galvanic Skin Response Measurement). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 155 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Meridian Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Meridian AG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Meridian AG’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 “Meridian”
FDA records each applicant name separately; these may or may not be the same firm.