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

DYH 2016-10-14

BracePaste Adhesive

Applicant American Orthodontics

K-Number K160782

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LPH 2016-10-14

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

Applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K-Number K161569

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LLZ 2016-10-14

NovaPACS

Applicant Novarad Corporation

K-Number K160371

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IYN 2016-10-14

MyLabSix CrystaLine

Applicant Esaote, S.p.A.

K-Number K162290

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DQA 2016-10-14

Fingertip Pulse Oximeter MD300CG11/MD300CG51

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K160268

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OWB 2016-10-14

ANYVIEW-500R Fluoroscopic Mobile X-Ray System

Applicant Ecotron Co., Ltd.

K-Number K160279

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DXZ 2016-10-14

VascuCel

Applicant Admedus Regen Pty, Ltd.

K-Number K162579

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LFL 2016-10-14

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K161882

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DXN 2016-10-14

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K161886

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GEX 2016-10-14

Olive Plus

Applicant Ama Network, Inc.

K-Number K161981

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LLZ 2016-10-14

MedDream

Applicant Softneta Uab

K-Number K162011

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CDZ 2016-10-14

FREND Testosterone Test System

Applicant Nanoentek USA, Inc.

K-Number K153577

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