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"
97–120 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Apr 12, 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101,...
K213234 · MHX
Ge Medical Systems Information...
Cardiovascular · 194d
Cleared Apr 01, 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
K213490 · MHX
Ge Medical Systems Information...
Cardiovascular · 151d
Cleared Mar 22, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8
K214039 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Mar 11, 2022
CardIQ Suite
K213725 · JAK
GE Medical Systems SCS
Radiology · 105d
Cleared Feb 18, 2022
Deep Learning Image Reconstruction
K213999 · JAK
Ge Medical Systems, LLC
Radiology · 59d
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Jan 20, 2022
SIGNA PET/MR
K213709 · OUO
Ge Medical Systems, LLC
Radiology · 57d
Cleared Jan 20, 2022
SIGNA Hero
K213668 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d
Cleared Dec 17, 2021
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex...
K213715 · JAK
Ge Medical Systems, LLC
Radiology · 23d
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Oct 22, 2021
FlightPlan for Liver
K210807 · LLZ
GE Medical Systems SCS
Radiology · 219d
Cleared Sep 17, 2021
Deep Learning Image Reconstruction
K212067 · JAK
Ge Healthcare Japan Corporation
Radiology · 77d
Cleared Sep 10, 2021
Versana Premier
K210438 · IYN
GE Medical Systems Ultrasound and...
Radiology · 210d
Cleared Aug 20, 2021
Discovery MI Gen2
K211846 · KPS
Ge Medical Systems, LLC
Radiology · 66d
Cleared Jul 27, 2021
PET VCAR
K211247 · KPS
GE Medical Systems SCS
Radiology · 92d
Cleared Jun 09, 2021
Vivid S60N / Vivid S70N
K211216 · IYN
GE Medical Systems Ultrasound and...
Radiology · 47d
Cleared May 13, 2021
SIGNA 7.0T
K211118 · LNH
Ge Medical Systems, LLC
Radiology · 28d
Cleared Apr 30, 2021
MAC 7 - Resting ECG Analysis System
K203786 · DPS
Ge Medical Systems Information...
Cardiovascular · 123d
Cleared Apr 28, 2021
AMX Navigate
K210982 · IZL
Ge Medical Systems, LLC
Radiology · 27d
Cleared Mar 05, 2021
Vivid E80/ Vivid E90/ Vivid E95
K202658 · IYN
GE Medical Systems Ultrasound and...
Radiology · 172d
Cleared Mar 02, 2021
MaxFOV 2
K203617 · JAK
Ge Medical Systems, LLC
Radiology · 81d
Cleared Feb 16, 2021
VesselIQ Xpress
K200626 · JAK
GE Medical Systems SCS
Radiology · 343d
Cleared Jan 15, 2021
ViewPoint 6
K203677 · LLZ
GE Medical Systems Ultrasound &...
Radiology · 29d