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"
97–120 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Mar 06, 2026
Bunkerhill Contrast CAC
K260166 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 02, 2026
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4,...
K253771 · NEY
Nanjing Devin Medical Technology Co.,...
General & Plastic Surgery · 96d
Cleared Mar 02, 2026
Clarius Ejection Fraction AI
K253593 · QIH
Clarius Mobile Health Corp.
Radiology · 105d
Cleared Mar 02, 2026
Microwave Ablation Device
K252632 · NEY
Nanjing Dewen Medical Technology Co.,...
General & Plastic Surgery · 194d
Cleared Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Feb 26, 2026
ANNE Maternal
K253021 · HGM
Sibel Health, Inc.
Obstetrics & Gynecology · 160d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814 · QNQ
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Feb 17, 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 357d