FDA applicant
Prometex, Inc.
FDA records 4 decisions for Prometex, Inc. (Houston, TX) from 1987 to 1990: 4 510(k) clearances. Most are in product codes EBG (Crown And Bridge, Temporary, Resin) and EWO (Audiometer). 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 Prometex, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Prometex, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Prometex, 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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