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"
217–240 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Nov 24, 2014
SIGNA PET/MR
K142098 · OUO
Ge Medical Systems, LLC
Radiology · 115d
Cleared Oct 10, 2014
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
K142323 · IYN
Ge Medical Systems Israel , Ltd.
Radiology · 51d
Cleared Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA...
K142085 · LNH
Ge Medical Systems, LLC
Radiology · 57d
Cleared Sep 25, 2014
Optima XR200amx, Optima XR220amx
K142383 · IZL
Ge Medical Systems, LLC
Radiology · 30d
Cleared Sep 18, 2014
DISCOVERY IQ
K141477 · KPS
Ge Medical Systems, LLC
Radiology · 106d
Cleared Sep 18, 2014
CORTEX ID SUITE
K141074 · KPS
Ge Medical Systems, LLC
Radiology · 146d
Cleared May 15, 2014
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
K133664 · KGI
Ge Medical Systems Ultrasound &...
Radiology · 167d
Cleared Apr 30, 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · DXJ
Ge Medical Systems Information...
Cardiovascular · 131d
Cleared Apr 24, 2014
DISCOVERY IGS 740
K133278 · OWB
GE Medical Systems SCS
Radiology · 182d
Cleared Apr 22, 2014
HEPATIC VCAR
K133649 · JAK
GE Medical Systems SCS
Radiology · 146d
Cleared Apr 11, 2014
REVOLUTION CT
K133705 · JAK
Ge Medical Systems, LLC
Radiology · 129d
Cleared Mar 25, 2014
ASIR-V
K133640 · JAK
Ge Medical Systems, LLC
Radiology · 118d
Cleared Mar 21, 2014
DISCOVERY PET/CT 710
K133657 · KPS
Ge Medical Systems, LLC
Radiology · 114d
Cleared Feb 21, 2014
MONITOR B40
K133576 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 93d
Cleared Jan 17, 2014
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
K132410 · JAK
Ge Medical Systems, LLC
Radiology · 168d
Cleared Dec 04, 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · DQK
Ge Medical Systems Information...
Cardiovascular · 121d
Cleared Nov 18, 2013
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
K132261 · IZF
Ge Medical Systems, LLC
Radiology · 122d
Cleared Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA...
K132376 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 108d
Cleared Sep 26, 2013
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K131885 · MUE
GE Medical Systems SCS
Radiology · 93d
Cleared Aug 30, 2013
OPTIMA CT660
K131576 · JAK
Ge Medical Systems, LLC
Radiology · 91d
Cleared Jun 26, 2013
MONITOR B40
K130584 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 113d
Cleared May 23, 2013
DISCOVERY MR750W 3.0T
K130115 · LNH
Ge Medical Systems, LLC
Radiology · 127d
Cleared May 01, 2013
MAC-LAB HEMODYNAMIC RECORDING SYSTEM
K130626 · DQK
Ge Medical Systems Information...
Cardiovascular · 54d
Cleared Apr 12, 2013
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
K130884 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 14d