FDA applicant
Star Medical Technologies, Inc.
FDA records 3 decisions for Star Medical Technologies, Inc. (Raleigh, NC) from 1997 to 1999: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 predicates, 1 of them its own earlier devices. 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 Star Medical Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Star Medical Technologies, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Star Medical Technologies, 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) ReportOther applicant names beginning “Star”
FDA records each applicant name separately; these may or may not be the same firm.