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

Filters: Cleared only ×
175,820 results
21337–21360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2019
LOSPA II Knee System
K192507 · JWH
Corentec Co., Ltd.
Orthopedic · 90d
Cleared Dec 11, 2019
NemoScan
K192571 · LLZ
Software Nemotec S.L.
Radiology · 84d
Cleared Dec 11, 2019
FUJIFILM Distal Cap Models 33-40
K193123 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Dec 11, 2019
HI-TORQUE InfilTrac Guide Wire Family
K193126 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Dec 11, 2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test...
K193132 · LCX
Hangzhou Clongene Biotech Co., Ltd.
Chemistry · 29d
Cleared Dec 11, 2019
TSolution One Total Knee Application
K193135 · OLO
THINK Surgical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K193167 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 26d
Cleared Dec 10, 2019
Single Use Aspiration Needle
K190239 · KTI
Olympus Medical Systems Corp.
Anesthesiology · 307d
Cleared Dec 10, 2019
Transpara
K192287 · QDQ
Screenpoint Medical B.V.
Radiology · 110d
Cleared Dec 10, 2019
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
K192319 · IYN
Samsung Medison Co., Ltd.
Radiology · 106d
Cleared Dec 10, 2019
Diode Laser 808nm
K192516 · GEX
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Dec 10, 2019
Health Line CT CVC
K192533 · FOZ
Health Line International Corporation
General Hospital · 85d
Cleared Dec 10, 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K192929 · MED
STERIS Corporation
General Hospital · 54d
Cleared Dec 09, 2019
Dental high speed handpiece, Dental low speed handpiece
K181900 · EFB
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 511d
Cleared Dec 09, 2019
CEDIA Benzodiazepine Assay
K190968 · JXM
Microgenics Corporation
Toxicology · 241d
Cleared Dec 09, 2019
Southern Implants MAX Implant System
K191054 · DZE
Southern Implants (Pty), Ltd.
Dental · 234d
Cleared Dec 09, 2019
EyeStat
K191700 · GZP
Blinktbi, Inc.
Neurology · 167d
Cleared Dec 09, 2019
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System,...
K191793 · HRS
Nebula Surgical Private Limited
Orthopedic · 159d
Cleared Dec 09, 2019
Straumann Mini Implants
K191895 · DZE
Institut Straumann AG
Dental · 147d
Cleared Dec 09, 2019
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear...
K192225 · LPL
Vizionfocus, Inc.
Ophthalmic · 115d
Cleared Dec 09, 2019
JETi Peripheral Thrombectomy System
K192439 · QEZ
Walk Vascular, LLC
Cardiovascular · 94d
Cleared Dec 09, 2019
FFRangio
K192442 · QEK
Cathworks, Ltd.
Cardiovascular · 94d
Cleared Dec 09, 2019
TSV BellaTek Express and BellaTek Flex Abutments
K192522 · NHA
Biomet 3i, LLC
Dental · 87d
Cleared Dec 09, 2019
C.T.M. Mobility Scooter HS-268
K192885 · INI
Chien TI Enterprise Co., Ltd.
Physical Medicine · 60d