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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

188 results for "third party"
145–168 of 188
Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Nov 03, 2017
PALLAS 308/311 Solid-State UV Laser System
K172639 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 63d
Cleared Oct 24, 2017
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot...
K171751 · MWI
Capsule Technologie Sas
Cardiovascular · 133d
Cleared Oct 18, 2017
OrthoView 7.2
K171068 · LLZ
Meridian Technique, Ltd.
Radiology · 191d
Cleared Aug 31, 2017
Medical Video Endoscope System
K172098 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 51d
Cleared Aug 16, 2017
Clear Blue Digi LED Curing Light
K172426 · EBZ
Promident, LLC
Dental · 6d
Cleared Jul 25, 2017
HP PRO Positioning Device
K171734 · IYE
Orfit Industries NV
Radiology · 43d
Cleared Jul 18, 2017
Inspire ICE aka Inspire ICE Clear Brackets
K171844 · NJM
Ormco Corporation
Dental · 28d
Cleared Jun 22, 2017
CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
K171591 · IYO
Mcube Technology Co., Ltd.
Radiology · 22d
Cleared May 26, 2017
Mistral-Air Warming Unit
K171234 · DWJ
The Surgical Company International BV...
Cardiovascular · 29d
Cleared May 05, 2017
Medical Video Endoscope System
K171076 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 24d
Cleared May 05, 2017
In Reach
K170789 · JAK
Curvebeam, LLC
Radiology · 50d
Cleared Apr 21, 2017
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
K170721 · GEI
Precision Surgical, LLC
General & Plastic Surgery · 43d
Cleared Feb 08, 2017
Transformair Indoor Air Purifier
K161468 · FRA
Transformair, LLC
General Hospital · 257d
Cleared Dec 16, 2016
COOLIEF Cooled Radiofrequency Kit
K163236 · GXI
Halyard Health, Inc.
Neurology · 29d
Cleared Nov 30, 2016
TubeClear Control Box and Clearing Stem
K163092 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 21, 2016
OptiLux LED Illuminator
K163185 · HBI
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Sep 20, 2016
SomnoDent ALPHA
K162306 · LRK
Somnomed, Inc.
Dental · 34d
Cleared Aug 25, 2016
DragonFly Surgical Drill System
K161376 · ERL
Grace Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Aug 05, 2016
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator...
K161877 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 28d
Cleared Jul 15, 2016
Comfort Cover
K161920 · IZH
Precision Dynamics Corporation
Radiology · 2d
Cleared Jul 06, 2016
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
K161314 · BTT
Flexicare Medical Limited.
Anesthesiology · 56d
Cleared Jun 22, 2016
CliniCloud Non-contact Thermometer, Model SPL1024
K161325 · FLL
Stethocloud Pty.Ltd (Clinicloud)
General Hospital · 41d
Cleared Apr 04, 2016
SMARTez elastomeric infusion pump
K151650 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 291d
Cleared Apr 01, 2016
PlasmaFlow
K160318 · JOW
Manamed, Inc.
Cardiovascular · 56d