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"
265–288 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 14, 2025
Disposable ureteral stent
K243830 · FAD
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 152d
Cleared May 14, 2025
Medical Image Post-processing Software (uOmnispace.CT)
K242624 · QIH
Shanghai United Imaging Healthcare...
Radiology · 253d
Cleared May 12, 2025
uWS-Angio Basic
K243632 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 168d
Cleared May 09, 2025
SKOUT system
K251126 · QNP
Iterative Health
Gastroenterology & Urology · 28d
Not Cleared May 09, 2025
Teal Wand
DEN240045 · SEP
Teal Health, Inc.
Microbiology · 255d
Cleared May 08, 2025
Clarius Median Nerve AI
K250226 · QIH
Clarius Mobile Health Corp.
Radiology · 101d
Cleared May 05, 2025
AeviceMD
K243603 · DSH
Aevice Health Pte. , Ltd.
Anesthesiology · 165d
Cleared Apr 30, 2025
Resolve Fundus Camera
K250683 · HKI
Optain Health, Inc.
Ophthalmic · 55d
Cleared Apr 30, 2025
LumiRex Bronchoscope
K243541 · EOQ
Contra Healthcare Solutions, LLC
Ear, Nose, Throat · 166d
Cleared Apr 28, 2025
Suture-TOOL System
K250977 · NEW
Suturion AB
General & Plastic Surgery · 28d
Cleared Apr 28, 2025
LumiRex Ureteroscope
K243532 · FGB
Contra Healthcare Solutions, LLC
Gastroenterology & Urology · 164d
Cleared Apr 28, 2025
uAngio AVIVA CX
K243376 · OWB
Shanghai United Imaging Healthcare...
Radiology · 180d
Cleared Apr 25, 2025
Neu Platform
K250153 · GYD
Neuhealth Digital , Ltd.
Neurology · 94d
Cleared Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · JLW
Siemens Healthcare Diagnostics
Chemistry · 158d
Cleared Apr 25, 2025
Infrared Thermometer
K243082 · FLL
Guangzhou Daxin Health Technology...
General Hospital · 207d
Cleared Apr 24, 2025
Sonu
K242214 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 269d
Cleared Apr 22, 2025
OcuMet Beacon (OCUB100)
K241931 · MYC
Ocusciences, Inc.
Ophthalmic · 295d
Cleared Apr 16, 2025
Clarius Prostate AI
K243853 · QIH
Clarius Mobile Health Corp.
Radiology · 121d
Cleared Apr 14, 2025
Merge Universal Viewer (MUV)
K250301 · LLZ
Merge Healthcare Incorporated
Radiology · 73d
Cleared Apr 11, 2025
Disposable ureteral access sheath
K243710 · FED
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 130d
Cleared Apr 11, 2025
FUJIFILM Processor EP-8000
K243260 · FET
Fujifilm Corporation
Gastroenterology & Urology · 178d
Cleared Apr 08, 2025
BunkerHill BMD
K242295 · KGI
BunkerHill Health
Radiology · 249d
Cleared Apr 03, 2025
syngo Dynamics (Version VA41D)
K242551 · QIH
Siemens Healthcare GmbH
Radiology · 219d
Cleared Apr 01, 2025
MR Contour DL
K242925 · QKB
Ge Healthcare
Radiology · 189d