FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,274 results for "health"
73–96 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 27, 2026
Synapse Lung Nodule AI
K254075 · OEB
Fujifilm Corporation
Radiology · 160d
Cleared May 26, 2026
4K NIR/ICG Imaging System
K260318 · GCJ
Zhejiang Healnoc Technology Co., Ltd.
General & Plastic Surgery · 116d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared May 22, 2026
Spectrum-2
K254129 · MUD
Neko Health AB
General & Plastic Surgery · 151d
Cleared May 22, 2026
AiSteth®
K252915 · DQD
Ai Health Highway India Pvt., Ltd.
Cardiovascular · 252d
Cleared May 21, 2026
BAC
K254131 · QIH
DeepHealth, Inc.
Radiology · 150d
Cleared May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite,...
K253720 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 178d
Cleared May 20, 2026
The Circadia C300 System (C300)
K261286 · DRT
Circadia Health, Inc.
Cardiovascular · 30d
Cleared May 20, 2026
Derma-2
K253911 · LHQ
Neko Health AB
Radiology · 163d
Cleared May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE...
K253716 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 172d
Cleared May 13, 2026
Morph
K260032 · QIH
BeauBrain Healthcare, Inc.
Radiology · 127d
Cleared Apr 30, 2026
Bayesian Health Sepsis Flagging Device
K250680 · SAK
Bayesian Health, Inc.
Gastroenterology & Urology · 420d
Cleared Apr 29, 2026
DeepHealth ProstateAI
K253682 · QDQ
Quantib B.V.
Radiology · 159d
Cleared Apr 29, 2026
Paptizer 360
K252471 · QXQ
LiViliti Health Products Corporation
General Hospital · 266d
Cleared Apr 28, 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · FYA
Cardinal Health 200, LLC
General Hospital · 211d
Cleared Apr 28, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B,...
K252501 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 263d
Cleared Apr 22, 2026
myosmart. (13E522)
K253256 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 205d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 21, 2026
Korotkoff sound blood pressure monitor
K253982 · DXN
Beijing Hanvon Health Technology Co.,...
Cardiovascular · 130d
Cleared Apr 16, 2026
Enso for Migraine
K254216 · PCC
Hinge Health, Inc.
Neurology · 108d
Cleared Apr 10, 2026
syngo Dynamics (VA41F)
K253689 · QIH
Siemens Healthcare GmbH
Radiology · 140d
Cleared Apr 10, 2026
AI-Rad Companion Organs RT
K252548 · QKB
Siemens Healthcare GmbH
Radiology · 240d
Cleared Apr 08, 2026
Profoject Enteral/Oral Feeding Syringe
K253268 · PNR
CMT Health PTE., Ltd.
Gastroenterology & Urology · 191d
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d