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
73–96 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 22, 2026
AV Vascular
K253735 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jan 16, 2026
Imagine® Enterprise Suite
K252634 · QIH
Softlink International Private Limited
Radiology · 149d
Cleared Dec 30, 2025
TruSPECT Processing Station
K253532 · QIH
Spectrum Dynamics Medical, Ltd.
Radiology · 47d
Cleared Dec 22, 2025
PeekMed web
K252856 · QIH
Peek Health, S.A.
Radiology · 104d
Cleared Dec 19, 2025
AI-CVD
K252029 · QIH
HeartLung Corporation
Radiology · 172d
Cleared Dec 19, 2025
Alzevita
K252670 · QIH
TOPIA MEDTECH LIMITED
Radiology · 116d
Cleared Dec 18, 2025
MediAI-BA
K250914 · QIH
Crescom Co., Ltd.
Radiology · 266d
Cleared Dec 18, 2025
PVAD IQ Software
K252235 · QIH
Ultrasight , Ltd.
Radiology · 154d
Cleared Dec 17, 2025
Neosoma Brain Mets
K252922 · QIH
Neosoma, Inc.
Radiology · 93d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 05, 2025
Overjet CBCT Assist
K251514 · QIH
Overjet, Inc.
Radiology · 203d
Cleared Dec 02, 2025
Acorn 3D Software (AC-SEG-4009)
K252103 · QIH
Mighty Oak Medical
Radiology · 152d
Cleared Nov 14, 2025
AutoDensity
K251078 · QIH
Eos Imaging
Radiology · 220d
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d
Cleared Nov 03, 2025
3mensio Workstation
K250330 · QIH
Pie Medical Imaging BV
Radiology · 271d
Cleared Oct 30, 2025
AiORTA - Plan
K250337 · QIH
ViTAA Medical Solutions, Inc.
Radiology · 266d
Cleared Oct 27, 2025
cvi42 Coronary Plaque Software Application
K251027 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 208d
Cleared Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059 · QIH
Siemens Healthineers AG
Radiology · 203d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 20, 2025
brAIn™ Shoulder Positioning
K252665 · QIH
Avatar Medical
Radiology · 56d
Cleared Oct 07, 2025
AIAS Cephalon
K252214 · QIH
Metamorphosis GmbH
Radiology · 84d
Cleared Oct 06, 2025
BlineSlide
K252007 · QIH
Deep Breathe, Inc.
Radiology · 101d
Cleared Sep 29, 2025
SMART PCFD
K250023 · QIH
Disior, Ltd.
Radiology · 269d