FDA applicant
Gps
FDA records 2 decisions for Gps (Port Washington, NY) in 1997: 2 510(k) clearances. Most are in product codes HFW (Clamp, Umbilical) and HIB (Speculum, Vaginal, Nonmetal). 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 Gps’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gps since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gps’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) Report