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"
433–456 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Aug 06, 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · KPS
Ge Medical Systems, Inc.
Radiology · 26d
Cleared Aug 01, 2002
ADVANTAGE WINDOWS X-RAY/MR FUSION
K022310 · LLZ
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Aug 01, 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193 · DQA
Ge Medical Systems Information...
Anesthesiology · 27d
Cleared Jul 02, 2002
DINAMAP PROCARE SERIES MONITOR
K014255 · MWI
Ge Medical Systems Information...
Cardiovascular · 188d
Cleared Jun 17, 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · IZL
GE Medical Systems
Radiology · 80d
Cleared May 22, 2002
HISPEED DUAL
K021491 · JAK
Ge Medical Systems, Inc.
Radiology · 13d
Cleared May 22, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
K021435 · MWI
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared May 09, 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929 · JAK
GE Medical Systems
Radiology · 12d
Cleared Mar 26, 2002
CARD IQ ANALYSIS II
K020796 · JAK
GE Medical Systems
Radiology · 14d
Cleared Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915 · MHX
Ge Medical Systems Information...
Cardiovascular · 203d
Cleared Feb 28, 2002
ADVANTAGE WORKSTATION 4.1
K020483 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Feb 01, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
K020022 · MWI
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
K013636 · LNH
GE Medical Systems
Radiology · 80d
Cleared Jan 10, 2002
GE LOGIQ 5
K014097 · IYN
GE Medical Systems
Radiology · 29d
Cleared Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 90d
Cleared Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
K013561 · JAK
GE Medical Systems
Radiology · 13d
Cleared Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · KPR
GE Medical Systems
Radiology · 14d
Cleared Oct 30, 2001
CARDIQ FUNCTION
K013422 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970 · LNH
GE Medical Systems
Radiology · 20d
Cleared Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · KPS
GE Medical Systems
Radiology · 29d
Cleared Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836 · JAK
GE Medical Systems
Radiology · 15d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · LNI
Ge Medical Systems, Inc.
Radiology · 90d