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

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175,820 results
25513–25536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2018
FilmArray Blood Culture Identification (BCID) Panel
K181493 · PEN
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Jul 04, 2018
Riptide Aspiration System React 68 Catheter
K180705 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 107d
Cleared Jul 04, 2018
React 68 Catheter
K180715 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 107d
Cleared Jul 03, 2018
Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
K172952 · EBF
Figaro Crowns, Inc.
Dental · 280d
Cleared Jul 03, 2018
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173679 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 214d
Cleared Jul 03, 2018
Ureterorenoscope System
K180367 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 141d
Cleared Jul 03, 2018
ETEST Telavancin (TLA) (0.002-32 ug/mL)
K180936 · JWY
Biomerieux S.A.
Microbiology · 84d
Cleared Jul 03, 2018
PeriView FLEX
K181193 · KTI
Olympus Surgical Technologies America
Ear, Nose, Throat · 60d
Cleared Jul 03, 2018
XRpad2 4343 HWC-M Flat Panel Detector
K181526 · MQB
Varex Imaging Corporation
Radiology · 22d
Cleared Jul 02, 2018
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
K173276 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 263d
Cleared Jul 02, 2018
Peekplus® Interbody Fusion Device
K173864 · MAX
Vallum Corporation
Orthopedic · 194d
Cleared Jul 02, 2018
Serenity Body Position Sensor, Serenity RIP Sensors
K173868 · OLV
Neurotronics, Inc.
Neurology · 194d
Cleared Jul 02, 2018
ULTRAPRO Mesh and ULTRAPRO ADVANCED
K180910 · FTL
Ethicon, Inc.
General & Plastic Surgery · 87d
Cleared Jul 01, 2018
qEEG-Pro
K171414 · OLU
Brainmaster Technologies, Inc.
Neurology · 412d
Cleared Jun 30, 2018
Zuga Dental Implant System
K171197 · DZE
Zuga Medical, Inc.
Dental · 432d
Cleared Jun 29, 2018
TubeClear System
K172556 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 309d
Cleared Jun 29, 2018
Ecolab POU Water Filter
K173164 · NHV
Ecolab, Inc.
Gastroenterology & Urology · 273d
Cleared Jun 29, 2018
Allergan Botox Needle Electrode
K173815 · IKT
Natus Manufacturing Limited
Neurology · 196d
Cleared Jun 29, 2018
Proton Positioing and Immobilization Devices
K180021 · IYE
Medtec Inc Dba Civco Medical...
Radiology · 177d
Cleared Jun 29, 2018
NuVasive Pulse System
K180038 · OLO
Nu Vasive, Incorporated
Orthopedic · 175d
Cleared Jun 29, 2018
Ensizor Monopolar Endoscopic Scissors
K180134 · KGE
Slater Endoscopy, LLC
Gastroenterology & Urology · 163d
Cleared Jun 29, 2018
Venera 508 Deep Vein Thrombosis (DVT) Prevention System
K180389 · JOW
Suzhou Minhua Medical Apparatus...
Cardiovascular · 136d
Cleared Jun 29, 2018
Servator B SALF Solution
K180481 · KDN
S.A.L.F. Spa
Gastroenterology & Urology · 126d
Cleared Jun 29, 2018
CREO® Stabilization System, REVERE® Stabilization System
K181068 · PGM
Globus Medical, Inc.
Orthopedic · 67d