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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: QIH ×
313 results
121–144 of 313
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 16, 2025
Clarius Prostate AI
K243853 · QIH
Clarius Mobile Health Corp.
Radiology · 121d
Cleared Apr 11, 2025
GBrain MRI
K250416 · QIH
Galileo Cds, Inc.
Radiology · 57d
Cleared Apr 10, 2025
cmAngio® (V1.6)
K250754 · QIH
Curemetrix, Inc.
Radiology · 29d
Cleared Apr 04, 2025
DeepFoqus (DeepFoqus-Accelerate)
K241982 · QIH
Foqus Technologies, Inc.
Radiology · 273d
Cleared Apr 03, 2025
syngo Dynamics (Version VA41D)
K242551 · QIH
Siemens Healthcare GmbH
Radiology · 219d
Cleared Apr 02, 2025
Hi-D Imaging 4TAVR
K241984 · QIH
Hi-D Imaging AG
Radiology · 268d
Cleared Mar 31, 2025
TribusConnect
K242166 · QIH
Tribusmed Beheer BV
Radiology · 250d
Cleared Mar 27, 2025
Salix Central
K243038 · QIH
Artrya Limited
Radiology · 181d
Cleared Mar 20, 2025
Vent Creativity Knee v1.0 (Hermes)
K241961 · QIH
Vent Creativity
Radiology · 260d
Cleared Mar 19, 2025
AVIEW
K243689 · QIH
Coreline Soft Co., Ltd.
Radiology · 110d
Cleared Mar 19, 2025
PeekMed web
K250042 · QIH
Peek Health, S.A.
Radiology · 70d
Cleared Mar 17, 2025
LVivo Software Application
K243862 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 91d
Cleared Mar 07, 2025
Cleerly LABS (v2.0)
K242338 · QIH
Cleerly, Inc.
Radiology · 212d
Cleared Mar 06, 2025
LVivo Seamless
K243331 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 133d
Cleared Mar 04, 2025
Ceevra Reveal 3+
K243933 · QIH
Ceevra, Inc.
Radiology · 74d
Cleared Mar 03, 2025
LVivo Software Application
K243235 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 144d
Cleared Feb 28, 2025
Myomics
K241922 · QIH
Phantomics, Inc.
Radiology · 242d
Cleared Feb 26, 2025
Ventripoint Medical System Plus (VMS+) 4.0
K241222 · QIH
Ventripoint Diagnostics , Ltd.
Radiology · 301d
Cleared Feb 21, 2025
ScanDiags Ortho L-Spine MR-Q
K242607 · QIH
Scandiags AG
Radiology · 171d
Cleared Feb 14, 2025
AVIEW CAC
K243696 · QIH
Coreline Soft Co., Ltd.
Radiology · 77d
Cleared Feb 12, 2025
SubtleHD (1.x)
K243250 · QIH
Subtle Medical, Inc.
Radiology · 120d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Philips Ultrasound, LLC
Radiology · 245d
Cleared Feb 05, 2025
BoneMetrics (US)
K241593 · QIH
Gleamer Sas
Radiology · 247d
Cleared Jan 23, 2025
TeraRecon Aorta.CT (1.1.0)
K243158 · QIH
Terarecon,Inc.
Radiology · 115d