Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NBW 2016-07-20

PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

Applicant Ok Biotech Co., Ltd.

K-Number K152599

View Details →

FLL 2016-07-20

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer

Applicant Arc Devices Limited

K-Number K152905

View Details →

OXO 2016-07-20

MultiScan G-Arm System

Applicant Beijing East Whale Imaging Technology Co., Ltd.

K-Number K160984

View Details →

KKY 2016-07-20

OsteoFab Patient Specific Facial Device

Applicant Oxford Performance Materials, Inc.

K-Number K161052

View Details →

IOR 2016-07-20

SUNCO Mechanical Wheelchair, model SKW-9003

Applicant Danyang Sunco Machinery Co., Ltd.

K-Number K153328

View Details →

GDW 2016-07-20

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload

Applicant Cardica, Inc.

K-Number K161137

View Details →

MEH 2016-07-19

Origin Coxa Vara Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K161155

View Details →

IYN 2016-07-19

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

Applicant Esaote, S.p.A.

K-Number K161359

View Details →

DXN 2016-07-19

ABPM 7100, Hypertension Management Software

Applicant I.E.M. GmbH

K-Number K153557

View Details →

PHL 2016-07-19

Ekso (version 1.1) and Ekso GT (version 1.2)

Applicant Ekso Bionics, Inc.

K-Number K161443

View Details →

MAI 2016-07-19

INTRAFIX(TM) Advance Tibial Fastener System

Applicant Medos International SARL

K-Number K160804

View Details →

MEH 2016-07-19

DePuy Actis DuoFix Hip Prosthesis

Applicant Depuy(Ireland)

K-Number K160907

View Details →

Page 2553 of 2685

↑