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

140 results for "third party"
121–140 of 140
Search insights Median review: 29d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use...
K181583 · BTM
Flexicare Medical Limited.
Anesthesiology · 175d
Cleared Nov 09, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · DYW
Blue Sky Bio
Dental · 73d
Cleared Oct 29, 2018
MC3 Vascular Access Kit 21030
K182914 · DRE
Mc3 Incorporated
Cardiovascular · 11d
Cleared Oct 18, 2018
TNI softFlow 50
K180474 · BTT
Tni Medical AG
Anesthesiology · 238d
Cleared Sep 11, 2018
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope...
K182196 · DQD
Imediplus, Inc.
Cardiovascular · 28d
Cleared Aug 21, 2018
MIDAScope and Introducer Kit, and MIDASystem
K181982 · HRX
Intravu, Inc.
General & Plastic Surgery · 27d
Cleared Aug 16, 2018
Luminelle DTx Hysteroscopy System
K181909 · FAJ
Uvision360, Inc.
Obstetrics & Gynecology · 30d
Cleared Aug 14, 2018
WiScope Digital Endoscope System
K181977 · FGB
OTU Medical, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 07, 2018
CubeVue
K181962 · LLZ
Curvebeam, LLC
Radiology · 15d
Cleared Aug 01, 2018
Smart One
K181666 · BZH
Mir Medical International Research
Anesthesiology · 37d
Cleared Jul 06, 2018
Endorate Valve Sets
K181509 · OCX
Smartdata Suzhou Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Jun 08, 2018
Sniper Infusion Catheter with Balloon Occlusion
K180904 · MJN
Embolx, Inc.
Cardiovascular · 63d
Cleared May 11, 2018
LineUp
K180727 · JAK
Curvebeam, LLC
Radiology · 52d
Cleared Apr 18, 2018
Stryker Universal Select Sterilization Tray System
K173615 · KCT
Paragon Medical
General Hospital · 147d
Cleared Mar 08, 2018
Accutension Smartphone Auscultatory Blood
K180335 · DXQ
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 30d
Cleared Feb 09, 2018
Blue Sky Bio Aligner
K180107 · NXC
Blue Sky Bio, LLC
Dental · 24d
Cleared Jan 25, 2018
CliniCloud Stethoscope
K173448 · DQD
Stethocloud Pty.Ltd (Clinicloud)
Cardiovascular · 80d
Cleared Jan 17, 2018
Kinsa QuickCare Thermometer
K173730 · FLL
Kinsa, Inc.
General Hospital · 42d
Cleared Mar 31, 2016
Proxis Ureteral Access Sheath
K160861 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 2d
Cleared Nov 13, 2015
LithoVue System
K153049 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 24d