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
9025–9048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
K220451 · DJG
Randox Laboratories Limited
Chemistry · 595d
Cleared Oct 04, 2023
The IQoolTM System
K232844 · DWJ
Braincool AB
Cardiovascular · 20d
Cleared Oct 04, 2023
Nautilus VF ECMO Oxygenator
K232767 · BYS
Mc3, Inc.
Cardiovascular · 23d
Cleared Oct 04, 2023
Electrode Handpieces (VCT, RFTV, BMDT series)
K232763 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 26d
Cleared Oct 04, 2023
Momentum Spine
K232023 · LDK
Momentum Health, Inc.
Physical Medicine · 89d
Cleared Oct 04, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231567 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 126d
Cleared Oct 04, 2023
VUNO Med-DeepBrain
K231398 · QIH
Vuno, Inc.
Radiology · 142d
Cleared Oct 04, 2023
EFAI NeuroSuite CT ICH Assessment System
K231025 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 176d
Cleared Oct 04, 2023
Copioumed Chemotherapy Isolation Gown
K230135 · FYC
Copioumed International, Inc.
General Hospital · 259d
Cleared Oct 03, 2023
enspire 300 Series Automated Endoscope Reprocessor
K232918 · NZA
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500)
K232914 · MED
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
dS Breast Coil 7ch 1.5T
K232762 · MOS
Invivo Corporation (Business Trade...
Radiology · 25d
Cleared Oct 03, 2023
endo.digital Platform
K232722 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 28d
Cleared Oct 03, 2023
uMI Panorama
K232712 · KPS
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Oct 03, 2023
KARL STORZ OR1™ SCB CONTROL (WU300)
K232406 · ODA
Karl Storz SE & CO. KG
General & Plastic Surgery · 54d
Cleared Oct 03, 2023
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE
K232230 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 68d
Cleared Oct 03, 2023
Orchid Safety Release ValveTM
K232094 · QOI
Linear Health Sciences, LLC
General Hospital · 82d
Cleared Oct 03, 2023
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach...
K231960 · QKZ
Anx Robotica Corporation
Gastroenterology & Urology · 92d
Cleared Oct 03, 2023
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6...
K231772 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Oct 03, 2023
Lung-CAD
K230085 · MYN
Imagen Technologies, Inc.
Radiology · 265d
Cleared Oct 02, 2023
Surgical face mask
K232359 · FXX
Kingstar Medical (Xianning) Co., Ltd.
General Hospital · 56d
Cleared Oct 02, 2023
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with...
K232064 · LZA
Isikel Manufacturing, LLC
General Hospital · 83d
Cleared Oct 02, 2023
OsteoFlo® HydroPutty™
K231716 · MQV
SurGenTec, LLC
Orthopedic · 111d
Cleared Oct 02, 2023
tmCMF Solution
K231520 · DZJ
Techmah Cmf
Dental · 130d