FDA applicant
Lori Medical Laboratories, Inc.
FDA records 8 decisions for Lori Medical Laboratories, Inc. (Golden Valley, MN) from 1989 to 1997: 8 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and KHL (Hearing Aid, Master). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lori Medical Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Lori Medical Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lori Medical Laboratories, Inc.’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) Report