GE Healthcare Finland Oy - FDA 510(k) Cleared Devices
Recent clearances: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE B650, E-musb, Carescape B850, E-musb
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - GE Healthcare Finland Oy Cardiovascular ✕
14 devices
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
Jan 29, 2020
Carescape B850
Cardiovascular
259d
Cleared
Jan 24, 2020
CARESCAPE B450
Cardiovascular
260d
Cleared
Jan 21, 2020
CARESCAPE B650
Cardiovascular
266d
Cleared
Jul 31, 2015
B40i Patient Monitor
Cardiovascular
219d
Cleared
Jan 16, 2014
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
Cardiovascular
157d
Cleared
Dec 04, 2013
CARESCAPE MONITOR B450
Cardiovascular
114d
Cleared
Aug 28, 2013
CARESCAPE MONITOR B650
Cardiovascular
120d
Cleared
Aug 28, 2013
CARESCAPE MONITOR B850
Cardiovascular
104d
Cleared
Oct 18, 2010
CARESCAPE MONITOR B650
Cardiovascular
70d
Cleared
Sep 23, 2009
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING...
Cardiovascular
22d