FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
5521–5544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2024
Microlyte Ag/Lidocaine
K211943 · FRO
Imbed Biosciences
General & Plastic Surgery · 1212d
Cleared Oct 16, 2024
Safe Secure Sterilization Pouches and Rolls
K242839 · FRG
Shenzhen Safesecure Medical Infection...
General Hospital · 27d
Cleared Oct 16, 2024
ONCOZENE Microspheres
K242794 · KRD
Varian Medical Systems, Inc.
Cardiovascular · 30d
Cleared Oct 16, 2024
Vy Spine™ VyLam™ Laminoplasty System
K242784 · NQW
Vy Spine, LLC
Orthopedic · 30d
Cleared Oct 16, 2024
JLK-CTP
K242556 · LLZ
JLK, Inc.
Radiology · 49d
Cleared Oct 16, 2024
Electrically powered wheelchair
K241632 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 132d
Cleared Oct 16, 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205,...
K241613 · DXN
Shenzhen Hbcare Technology Co.,Ltd
Cardiovascular · 133d
Cleared Oct 16, 2024
xvision Spine System
K241481 · SBF
Augmedics, Ltd.
Orthopedic · 145d
Cleared Oct 16, 2024
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · FYA
Stryker Instruments
General Hospital · 163d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241244 · QJP
Cerenovus, Inc.
Neurology · 167d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241221 · NRY
Cerenovus, Inc.
Neurology · 168d
Cleared Oct 16, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K240849 · FAJ
Ambu A/S
Gastroenterology & Urology · 203d
Cleared Oct 16, 2024
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · MUD
Edwards Lifesciences
Neurology · 226d
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