FDA applicant
Healex Products, Inc.
FDA records 3 decisions for Healex Products, Inc. (Providence, RI) from 1996 to 2003: 3 510(k) clearances. Most are in product codes EJI (Syringe, Cartridge) and EBG (Crown And Bridge, Temporary, Resin). 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 Healex Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Healex Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Healex Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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