FDA applicant
Mednext, Inc.
FDA records 7 decisions for Mednext, Inc. (West Point Beach, FL) from 1993 to 1998: 7 510(k) clearances. Most are in product codes HBE (Drills, Burrs, Trephines & Accessories…) and HWE (Instrument, Surgical, Orthopedic, Ac-Powered…). 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 Mednext, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Mednext, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mednext, 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