Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: QIH ×
334 results
145–168 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jan 22, 2025
Rapid Neuro3D
K243350 · QIH
Ischemaview, Inc.
Radiology · 86d
Cleared Jan 02, 2025
Ortho AI
K241696 · QIH
Ortho Ai, LLC
Radiology · 204d
Cleared Jan 02, 2025
Ezra Flash
K242334 · QIH
Ezra Ai, Inc.
Radiology · 148d