Ge Medical Systems Information Technologies - FDA 510(k) Cleared Devi...
136
Total
132
Cleared
0
Denied
136 devices
Cleared
Dec 07, 1987
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
Cardiovascular
237d
Cleared
Nov 23, 1987
MODEL 500E INFANT MONITORING SYSTEM
Anesthesiology
67d
Cleared
Aug 10, 1987
SSD-725 ULTRASOUND SECTOR SCANNER
Cardiovascular
180d
Cleared
Jul 24, 1987
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
Cardiovascular
107d
Cleared
Jul 21, 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
Cardiovascular
137d
Cleared
Mar 27, 1987
280SL IMAGING SYSTEM TRANVAGINAL PROBES
Obstetrics & Gynecology
155d
Cleared
Jan 27, 1987
280SL IMAGING SYSTEM SMALL PARTS PROBES
Radiology
98d
Cleared
Jan 27, 1987
260SL IMAGING SYSTEM SMALL PARTS PROBES
Radiology
98d
Cleared
Aug 25, 1986
860 COLOR DOPPLER OR COLORVIEW 860
Radiology
123d
Cleared
Jul 31, 1986
645OB SECTOR/LINEAR ULTRASOUND SCANNER
Obstetrics & Gynecology
72d
Cleared
Jul 10, 1986
515A NEO-TRAK NEONATAL MONITOR
Anesthesiology
57d
Cleared
May 16, 1986
MODEL 535 NEO-TRAK RECORDER
Cardiovascular
150d
Cleared
May 14, 1986
NEO-TRAK 502 INFANT MONITOR
Anesthesiology
29d
Cleared
Sep 27, 1985
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
Obstetrics & Gynecology
100d
Cleared
Jul 05, 1985
MODEL 145 FETAL MONITOR
Obstetrics & Gynecology
53d
Cleared
Jun 24, 1985
COROMETRICS 500 INFANT MONITOR
Anesthesiology
136d
Cleared
May 22, 1985
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
Obstetrics & Gynecology
56d
Cleared
Dec 17, 1984
COROMETRICS FETAL MONITOR 142
Obstetrics & Gynecology
73d
Cleared
Nov 29, 1984
COROMETRICS 115 FETAL MONITOR
Obstetrics & Gynecology
93d
Cleared
Sep 19, 1984
OB ULTRASOUND LINEAR SCANNER 630
Obstetrics & Gynecology
104d
Cleared
May 14, 1984
COROMETRICS 815 FETAL ECG RECORDER
Obstetrics & Gynecology
35d
Cleared
Apr 23, 1984
LINEAR SCANNER 640
Radiology
66d
Cleared
Jan 27, 1984
TREND PROCESSOR OPTION FOR #515 NEONAT
Cardiovascular
105d
Cleared
Aug 11, 1983
FETAL MONITOR #115
Obstetrics & Gynecology
63d
Cleared
Jul 19, 1983
TRANSCUTANEOUS OXYGEN MONITOR OPTION
Anesthesiology
49d
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