Laboratorios Biogalenic S.A. DE C.V. - FDA 510(k) Cleared Devices
Recent clearances: Laboratorios Biogalenic Sterile Water for Inhalation, USP, Sterile Water USP and Sterile 0.9% Normal Saline USP, Laboratorios Biogalenic Sterile Water for Inhalation, USP
3
Total
3
Cleared
0
Denied
Laboratorios Biogalenic S.A. DE C.V. has 3 FDA 510(k) cleared medical devices. Based in San Salvador, SV.
Latest FDA clearance: Jan 2026. Active since 2025. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Laboratorios Biogalenic S.A. DE C.V. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Liberty Management Group , Ltd. and Herschel J. Gaddy & Associates.
FDA 510(k) Regulatory Record - Laboratorios Biogalenic S.A. DE C.V.
3 devices
Cleared
Jan 14, 2026
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Anesthesiology
252d
Cleared
Mar 06, 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
General & Plastic Surgery
161d
Cleared
Jan 30, 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Anesthesiology
142d