FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: QIH ×
321 results
1–24 of 321
Search insights Median review: 140d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 26, 2026
Heartvue.Proton
K260811 · QIH
Heartvue.ai, Inc.
Radiology · 167d
Cleared Aug 25, 2026
Ceevra Reveal 4
K261595 · QIH
Ceevra, Inc.
Radiology · 103d
Cleared Aug 21, 2026
BoneMRI
K260584 · QIH
Mriguidance B.V.
Radiology · 182d
Cleared Aug 21, 2026
DS Core CBCT Anatomy
K262127 · QIH
Dentsply Sirona
Radiology · 58d
Cleared Aug 18, 2026
Lower Limb AI (LLAI)
K261641 · QIH
AI Planning Logic, Inc.
Radiology · 92d
Cleared Aug 10, 2026
Prostate Core
K253794 · QIH
Lucida Medical, Ltd.
Radiology · 255d
Cleared Aug 07, 2026
mdprostate
K252571 · QIH
Mediaire GmbH
Radiology · 358d
Cleared Aug 04, 2026
RealGUIDE
K253902 · QIH
3DIEMME SRL
Radiology · 242d
Cleared Jul 31, 2026
Affinity
K253835 · QIH
Hermes Medical Solutions AB
Radiology · 242d
Cleared Jul 30, 2026
cmAngio® V2.0
K260980 · QIH
Curemetrix, Inc.
Radiology · 127d
Cleared Jul 29, 2026
Cleerly Plaque
K261210 · QIH
Cleerly, Inc.
Radiology · 106d
Cleared Jul 24, 2026
DIANA
K260192 · QIH
ROPCA ApS
Radiology · 183d
Cleared Jul 24, 2026
SwiftMR
K261349 · QIH
Airs Medical, Inc.
Radiology · 91d
Cleared Jul 23, 2026
VELMENI for DENTISTS (V4D) 3D
K254096 · QIH
Velmeni, Inc.
Radiology · 216d
Cleared Jul 20, 2026
Hi-D Imaging 4TAVR
K261535 · QIH
Hi-D Imaging AG
Radiology · 73d
Cleared Jul 15, 2026
SkeletonPlanner
K260206 · QIH
UPlanner B.V. - Presurgeo
Radiology · 173d
Cleared Jul 07, 2026
InferOperate Suite
K260973 · QIH
Beijing Infervision Healthcare...
Radiology · 105d
Cleared Jun 25, 2026
syngo.CT Coronary Cockpit
K253786 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 211d
Cleared Jun 18, 2026
Synapse PACS (7.6.0)
K261713 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 27d
Cleared Jun 15, 2026
MediAI-OA
K253172 · QIH
Crescom Co., Ltd.
Radiology · 262d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared Jun 15, 2026
WatchMate Software
K260300 · QIH
Anumana, Inc.
Radiology · 136d
Cleared Jun 12, 2026
Brainomix 360 Hyperdensity
K260406 · QIH
Brainomix Limited
Radiology · 123d
Cleared Jun 11, 2026
Acorn 3D Software (AC-SEG-4009)
K260322 · QIH
Mighty Oak Medical
Radiology · 132d