FDA applicant
Paradigm Medical, Inc.
FDA records 3 decisions for Paradigm Medical, Inc. (Northbrook, IL) from 1990 to 2022: 3 510(k) clearances. Most are in product codes KYZ (Syringe, Irrigating (Non Dental)) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Paradigm Medical Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Paradigm Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Paradigm Medical, 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) ReportOther applicant names beginning “Paradigm”
FDA records each applicant name separately; these may or may not be the same firm.