FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

710 results for "GE Medical Systems"
361–384 of 710
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Aug 27, 2004
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · DPS
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Aug 26, 2004
INNOVA 4100, INNOVA 3100
K042053 · OWB
Ge Medical Systems, Inc.
Radiology · 27d
Cleared Jul 26, 2004
GE SIGNA PROFILE 6 INCH GP COIL
K041921 · MOS
Ge Medical Systems, LLC
Radiology · 10d
Cleared Jul 23, 2004
GE LOGIQ 7 ULTRASOUND BT04
K041813 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 17d
Cleared Jun 17, 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
K041476 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 15, 2004
GE DISCOVERY ST SYSTEM
K041220 · KPS
GE Medical Systems
Radiology · 36d
Cleared Jun 04, 2004
MODIFICATION TO UNITY NETWORK ID
K040559 · MWI
Ge Medical Systems Information...
Cardiovascular · 93d
Cleared Jun 03, 2004
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K040458 · MHX
Ge Medical Systems Information...
Cardiovascular · 101d
Cleared Apr 19, 2004
SENOGRAPHIC STEREO
K040125 · IZH
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Apr 07, 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · KPS
GE Medical Systems
Radiology · 72d
Cleared Mar 24, 2004
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
K040050 · LLZ
Ge Medical Systems Navigation and...
Radiology · 72d
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Jan 15, 2004
SOLAR 9500 INFORMATION MONITOR
K033964 · MHX
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Dec 30, 2003
MYOLIGHT
K033874 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 18, 2003
MODIFICATION TO UNITY NETWORK ID
K033672 · MWI
Ge Medical Systems Information...
Cardiovascular · 24d
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