GE Healthcare Finland Oy is one of 16058 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
GE Healthcare Finland Oy - FDA 510(k) Cleared Devices
Recent clearances: Carescape ONE, Carescape Canvas 1000, CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
32
Total
32
Cleared
0
Denied
GE Healthcare Finland Oy has 32 FDA 510(k) cleared medical devices. Based in Madison, US.
Latest FDA clearance: Sep 2026. Active since 2007. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by GE Healthcare Finland Oy Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by GE Healthcare as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - GE Healthcare Finland Oy
32 devices
Cleared
Sep 01, 2026
Carescape ONE
Cardiovascular
186d
Cleared
Aug 28, 2026
Carescape Canvas 1000
Cardiovascular
207d
Cleared
Apr 06, 2023
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19,...
Cardiovascular
134d
Cleared
Apr 13, 2022
CARESCAPE B650, E-musb
Cardiovascular
196d
Cleared
Apr 13, 2022
Carescape B850, E-musb
Cardiovascular
189d
Cleared
Apr 13, 2022
CARESCAPE B450, E-musb
Cardiovascular
183d
Cleared
Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
Anesthesiology
185d
Cleared
Jan 29, 2020
Carescape B850
Cardiovascular
259d
Cleared
Jan 24, 2020
CARESCAPE B450
Cardiovascular
260d
Cleared
Jan 22, 2020
E-EEGX, N-EEGX
Neurology
252d
Cleared
Jan 21, 2020
CARESCAPE B650
Cardiovascular
266d
Cleared
May 01, 2019
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
Anesthesiology
145d