FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

719 results for "GE Medical Systems"
385–408 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Dec 04, 2003
SENO ADVANTAGE
K033400 · LLZ
Ge Medical Systems W-400
Radiology · 41d
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492 · MHX
Ge Medical Systems Information...
Cardiovascular · 20d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · JAK
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K033304 · MHX
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Nov 06, 2003
APEXPRO FH TELEMETRY SYSTEM
K033365 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915 · JAK
Ge Medical Systems, LLC
Radiology · 38d
Cleared Oct 30, 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · DQK
Ge Medical Systems Information...
Cardiovascular · 77d
Cleared Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · OWB
Ge Medical Systems, Inc.
Radiology · 9d
Cleared Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · DQK
Ge Medical Systems Information...
Cardiovascular · 50d
Cleared Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
K032795 · LNH
Ge Medical Systems, LLC
Radiology · 30d
Cleared Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
K032582 · MSX
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Aug 22, 2003
INNOVA 3100
K031637 · OWB
GE Medical Systems
Radiology · 87d
Cleared Aug 21, 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared Aug 15, 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
K032369 · MHX
Ge Medical Systems Information...
Cardiovascular · 14d
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370 · DSI
Ge Medical Systems Information...
Cardiovascular · 12d
Cleared Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
K032346 · MSX
Ge Medical Systems Information...
Cardiovascular · 6d
Cleared Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
K031561 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Jul 30, 2003
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · MOS
GE Medical Systems
Radiology · 28d
Cleared Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376 · MHX
Ge Medical Systems Information...
Cardiovascular · 76d
Cleared Jul 02, 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927 · LNH
GE Medical Systems
Radiology · 9d
Cleared Jun 20, 2003
AUTOBONE
K031871 · JAK
Ge Medical Systems Europe
Radiology · 3d
Cleared May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
K031209 · MOS
Ge Medical Systems, Inc.
Radiology · 36d
Cleared May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396 · LNH
GE Medical Systems
Radiology · 11d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · MHX
Ge Medical Systems Information...
Cardiovascular · 260d