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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
49–72 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Apr 06, 2026
Ricoh 3D for Healthcare Bolus
K253025 · IXI
Ricoh 3D For Healthcare, LLC
Radiology · 199d
Cleared Apr 03, 2026
uMI Panvivo (uMI Panvivo LS)
K260524 · KPS
Shanghai United Imaging Healthcare...
Radiology · 45d
Cleared Apr 01, 2026
CoLumbo C-Spine
K254015 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared Mar 26, 2026
DeVilbiss 5 Liter Oxygen Concentrator (555)
K253549 · CAW
Devilbiss Healthcare, LLC
Anesthesiology · 132d
Cleared Mar 23, 2026
True Definition DL
K253686 · JAK
Ge Healthcare Japan Corporation
Radiology · 122d
Cleared Mar 23, 2026
CT Rembra RT
K252992 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 186d
Cleared Mar 20, 2026
Smart Fit TorsoCardiac 1.5T
K260519 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 31d
Cleared Mar 17, 2026
Cala kIQ Plus
K253587 · QBC
Cala Health, Inc.
Neurology · 120d
Cleared Mar 16, 2026
Data Analysis Facilitation Suite (DAFS)
K253944 · QIH
Voronoi Health Analytics Incorporated
Radiology · 96d
Cleared Mar 13, 2026
InferCare RECIST
K252261 · QIH
Beijing Infervision Healthcare...
Radiology · 235d
Cleared Mar 12, 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · EZD
HR Healthcare
Gastroenterology & Urology · 27d
Cleared Mar 11, 2026
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
K253185 · IZL
Carestream Health
Radiology · 166d
Cleared Mar 09, 2026
Medicell Mycosis Laser (MCML24004)
K253960 · PDZ
Medicell Healthcare Co.,LTD
General & Plastic Surgery · 89d
Cleared Mar 09, 2026
FUJIFILM Endoscope Model ED-S100TP
K251861 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 265d
Cleared Mar 06, 2026
Bunkerhill Contrast AVC
K260167 · JAK
BunkerHill Health
Radiology · 45d