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"

169–188 of 188

Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental

Cleared Mar 31, 2016

Proxis Ureteral Access Sheath

C.R. Bard, Inc.

Gastroenterology & Urology · 2d

Cleared Dec 28, 2015

Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera...

Paragon Medical, Inc.

General Hospital · 83d

Cleared Nov 13, 2015

LithoVue System

Boston Scientific Corporation

Gastroenterology & Urology · 24d

Cleared Nov 02, 2015

Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light...

First Quality Hygienic, Inc.

Obstetrics & Gynecology · 154d

Cleared Sep 16, 2015

ELUMI 810 + 980 Soft Tissue Laser

Azena Medical, LLC

General & Plastic Surgery · 56d

Cleared Jul 30, 2015

SmartDrive Wheelchair Power Assist

Max Mobility, LLC

Physical Medicine · 86d

Cleared Jul 08, 2015

Arrow Endurance Extended Dwell Peripheral Catheter System

Arrow Internation, Inc. (Subsidiary...

General Hospital · 34d

Cleared Jul 02, 2015

Tosama 100% Organic Cotton Menstrual Tampon

Obstetrics & Gynecology · 62d

Cleared Jun 11, 2015

Tek RMD (Tek Robotic Mobilization Device)

Matia Robotics Mekatroik Sis. Ar-Ge...

Physical Medicine · 100d

Cleared Jun 10, 2015

Buffalo Filter, LLC

General & Plastic Surgery · 96d

Cleared Apr 17, 2015

UnicLine Mobile

Heka Dental A/S

Cleared Apr 02, 2015

QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve...

Cymedica Orthopedics, Inc.

Physical Medicine · 43d

Cleared Feb 24, 2015

Photonica Professional

Ward Photonics, LLC

General & Plastic Surgery · 14d

Cleared Feb 04, 2015

Laparoscopic Handles with peek Insulation

Stryker Endoscopy

General & Plastic Surgery · 15d

Cleared Jan 22, 2015

Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White...

Central Medicare Sdn Bhd

General Hospital · 71d

Cleared Dec 23, 2014

Nice Recovery Systems, LLC

Physical Medicine · 47d

Cleared Dec 15, 2014

The Panthera Anti-Snoring Device

Panthera Dental, Inc.

Cleared Oct 23, 2014

Stryker Precision HD Camera System

Stryker Endoscopy

General & Plastic Surgery · 38d

Cleared Oct 07, 2014

888 WNLE POWERED WHEELCHAIR

Pihsiang Machinery Mfg. Co., Ltd.

Physical Medicine · 74d

Cleared Apr 15, 2014

FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER

Boston Scientific

General & Plastic Surgery · 47d