Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

ORC 2016-07-20

Operio

Applicant Toul Meditech AB

K-Number K153498

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OAN 2016-07-20

St. Louis Band

Applicant Orthomerica Products, Inc.

K-Number K161138

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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

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FLL 2016-07-20

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

Applicant Arc Devices Limited

K-Number K152905

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OXO 2016-07-20

MultiScan G-Arm System

Applicant Beijing East Whale Imaging Technology Co., Ltd.

K-Number K160984

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KKY 2016-07-20

OsteoFab Patient Specific Facial Device

Applicant Oxford Performance Materials, Inc.

K-Number K161052

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IOR 2016-07-20

SUNCO Mechanical Wheelchair, model SKW-9003

Applicant Danyang Sunco Machinery Co., Ltd.

K-Number K153328

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GDW 2016-07-20

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

Applicant Cardica, Inc.

K-Number K161137

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MEH 2016-07-19

Origin Coxa Vara Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K161155

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IYN 2016-07-19

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

Applicant Esaote, S.p.A.

K-Number K161359

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DXN 2016-07-19

ABPM 7100, Hypertension Management Software

Applicant I.E.M. GmbH

K-Number K153557

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PHL 2016-07-19

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

Applicant Ekso Bionics, Inc.

K-Number K161443

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