FDA applicant
Porex Medical
FDA records 15 decisions for Porex Medical (Fairburn, GA) from 1983 to 1987: 15 510(k) clearances. Most are in product codes FWP (Prosthesis, Chin, Internal) and HPZ (Implant, Eye Sphere). 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Porex Medical’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Porex Medical since 2007.
Recalls per year
2in 2017
Class I Class II/III not classified
Planning a device like Porex Medical’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 “Porex”
FDA records each applicant name separately; these may or may not be the same firm.