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"
217–240 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 30, 2025
ViVi® Toga Premium
K243522 · FYA
Thi Total Healthcare Innovation GmbH
General Hospital · 197d
Cleared May 28, 2025
CoLumboX
K250367 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 220d
Cleared May 21, 2025
uMR Omega
K243122 · LNH
Shanghai United Imaging Healthcare...
Radiology · 233d
Cleared May 20, 2025
SCENARIA View Phase 5.0
K250370 · JAK
Fujifilm Corporation
Radiology · 99d
Cleared May 19, 2025
Diagnostic X-ray System
K243411 · OWB
Nanjing Perlove Medical Equipment...
Radiology · 199d
Cleared May 16, 2025
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · JAK
Shanghai United Imaging Healthcare...
Radiology · 175d
Cleared May 15, 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 296d
Cleared May 14, 2025
CaloPix
K250414 · QKQ
Tribun Health
Pathology · 90d
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