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

Filters: Cleared only ×
175,230 results
5809–5832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2024
Alkaline Phosphatase
K240468 · CJE
Abbott Laboratories Diagnostics Division
Chemistry · 239d
Cleared Oct 16, 2024
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
K240364 · LKF
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 253d
Cleared Oct 16, 2024
UltraEzAir® (UEA1A)
K240114 · CCT
Dualams, Inc., Dba Airkor
Anesthesiology · 274d
Cleared Oct 15, 2024
Getinge Assured MI Steam Migrating Integrator
K242795 · JOJ
Steritec Products Mfg. (A Getinge...
General Hospital · 29d
Cleared Oct 15, 2024
cvi42 Software Application
K242781 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 29d
Cleared Oct 15, 2024
TauTona Pneumoperitoneum Assist Device (TPAD)
K242536 · HIF
Tautona Group
Obstetrics & Gynecology · 50d
Cleared Oct 15, 2024
DenMat Bulk Fill Composite
K242097 · EBF
Den-Mat Holdings, LLC
Dental · 89d
Cleared Oct 15, 2024
Artix™ MT
K241894 · QEW
Inari Medical, Inc.
Cardiovascular · 109d
Cleared Oct 15, 2024
Denture Base Resin (PN-Denture (Red, White))
K241673 · EBF
Shenzhen Piocreat 3D Technology Co.,...
Dental · 126d
Cleared Oct 15, 2024
VINT
K240385 · LLZ
Mediimg Corporation
Radiology · 250d
Cleared Oct 15, 2024
Single-use Extraction Baskets
K240192 · LQR
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Oct 15, 2024
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K231997 · ILY
Cure Point Therapeutics, Inc.
General & Plastic Surgery · 468d
Cleared Oct 12, 2024
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
K242812 · LZA
Nb Medical Company Limited
General Hospital · 24d
Cleared Oct 11, 2024
Legend® Acetabular Shell
K242833 · LPH
Ortho Development Corp.
Orthopedic · 22d
Cleared Oct 11, 2024
Hood (DH-083ST)
K242779 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Oct 11, 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · MUH
Qpix Solutions, Inc.
Radiology · 28d
Cleared Oct 11, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K242742 · ODC
STERIS Corporation
Gastroenterology & Urology · 30d
Cleared Oct 11, 2024
Mobility Scooter (N3473)
K242387 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 60d
Cleared Oct 11, 2024
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)
K242133 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 81d
Cleared Oct 11, 2024
Access Toxo IgM II
K242095 · LGD
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Oct 11, 2024
Accure Laser System
K242035 · GEX
Accure Acne, Inc.
General & Plastic Surgery · 91d
Cleared Oct 11, 2024
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
K241971 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Oct 11, 2024
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
K241857 · OHS
Dongguan Boyuan Intelligent...
General & Plastic Surgery · 106d
Cleared Oct 11, 2024
syngo Application Software
K241569 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 133d