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
169–192 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 19, 2024
OrthoNext Platform System
K242270 · QIH
Orthofix Srl
Radiology · 140d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 16, 2024
MSKai
K240793 · QIH
Mskai
Radiology · 269d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Intuitive Surgical, Inc.
Radiology · 113d
Cleared Dec 06, 2024
CDM Insights
K240680 · QIH
Oxford Brain Diagnostics, Ltd.
Radiology · 270d
Cleared Dec 06, 2024
DrAid™ for Liver Segmentation
K241543 · QIH
Vinbrain Joint Stock Company
Radiology · 189d
Cleared Nov 27, 2024
Sonix Health
K240645 · QIH
Ontact Health Co., Ltd.
Radiology · 265d
Cleared Nov 22, 2024
BriefCase-Quantification
K242203 · QIH
Aidoc Medical , Ltd.
Radiology · 119d
Cleared Nov 20, 2024
Strain AI (SAI001)
K242359 · QIH
Exo, Inc.
Radiology · 103d
Cleared Nov 05, 2024
TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312 · QIH
Terarecon,Inc.
Radiology · 180d
Cleared Oct 30, 2024
RemedyLogic AI MRI Lumbar Spine Reader
K241108 · QIH
Remedy Logic, Inc.
Radiology · 191d
Cleared Oct 25, 2024
Neurophet AQUA (V3.1)
K242215 · QIH
Neurophet., Inc.
Radiology · 88d
Cleared Oct 25, 2024
TumorSight Viz
K243189 · QIH
SimBioSys, Inc.
Radiology · 25d
Cleared Oct 15, 2024
cvi42 Software Application
K242781 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 29d
Cleared Oct 10, 2024
AutoChamber
K240786 · QIH
HeartLung Corporation
Radiology · 202d
Cleared Oct 10, 2024
EchoMeasure
K241430 · QIH
Icardio.Ai
Radiology · 142d
Cleared Oct 04, 2024
LVivo Software Application
K240553 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 219d
Cleared Oct 02, 2024
MammoScreen BD
K241561 · QIH
Therapixel
Radiology · 124d
Cleared Oct 01, 2024
LungVision
K240943 · QIH
Bodyvision Medical , Ltd.
Radiology · 179d
Cleared Sep 20, 2024
PIUR tUS Infinity
K240036 · QIH
Piur Imaging GmbH
Radiology · 259d
Cleared Sep 12, 2024
Constellation (CON-001)
K241280 · QIH
Q Bio, Inc.
Radiology · 128d
Cleared Sep 10, 2024
LumiNE US
K240094 · QIH
Augmedit B.V.
Radiology · 242d
Cleared Sep 09, 2024
ADAS 3D
K240791 · QIH
Adas3D Medical S.L.
Radiology · 171d
Cleared Sep 09, 2024
Overjet Image Enhancement Assist
K241681 · QIH
Overjet, Inc.
Radiology · 90d