Phelcom Technologies is one of 50 FDA 510(k) medical device manufacturers from Brazil in the dataset, ranked by real submission volume.
Phelcom Technologies - FDA 510(k) Cleared Devices
Recent clearances: Eyer 2, Eyer Retinal Camera NM-STD
2
Total
2
Cleared
0
Denied
Phelcom Technologies has 2 FDA 510(k) cleared medical devices. Based in S?o Carlos, BR.
Latest FDA clearance: Jan 2026. Active since 2023. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Phelcom Technologies Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Passarini Regulatory Affairs of America, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Phelcom Technologies
2 devices