General Electric Co. - FDA 510(k) Cleared Devices
Recent clearances: GE VEO RECONSTRUCTION OPTION, GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION, GE VIVID E9 ULTRASOUND
254
Total
254
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Electric Co. Cardiovascular ✕
15 devices
Cleared
Nov 29, 1988
TRANSESOPHAGEAL ECHO TRANSDUCER
Cardiovascular
76d
Cleared
Jun 01, 1988
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
Cardiovascular
292d
Cleared
Mar 02, 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
Cardiovascular
315d
Cleared
Oct 20, 1987
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
Cardiovascular
238d
Cleared
Dec 29, 1981
MICRO-PREPROCESSOR UNIT
Cardiovascular
71d
Cleared
Mar 27, 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
Cardiovascular
7d
Cleared
Mar 20, 1981
DUO-TEL
Cardiovascular
39d
Cleared
Nov 26, 1980
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
Cardiovascular
64d
Cleared
Sep 26, 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
Cardiovascular
23d
Cleared
Aug 27, 1980
MICRO-PROCESSOR UNIT #A3600AC
Cardiovascular
30d
Cleared
Aug 20, 1980
PDS COMPUTER UNIT/VIDEO TERMINAL
Cardiovascular
23d
Cleared
Jan 12, 1978
ARRHYTHMIA MODULE
Cardiovascular
16d