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

IZL 2016-07-06

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

Applicant Sedecal., Sa.

K-Number K161345

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MBI 2016-07-06

Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm

Applicant Dunamis, LLC

K-Number K160996

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DXN 2016-07-06

SunTech CT40 Spot-check Vital Signs Device

Applicant Suntech Medical

K-Number K160439

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BTT 2016-07-06

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

Applicant Flexicare Medical Limited.

K-Number K161314

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FMI 2016-07-06

BD SafeAssist

Applicant Becton, Dickinson and Company

K-Number K161553

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KPR 2016-07-06

GC85A

Applicant Samsung Electronics Co., Ltd.

K-Number K160997

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DJC 2016-07-06

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K161044

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KTT 2016-07-06

Integra External Fixation System

Applicant Ascension Orthopedics

K-Number K160830

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EMA 2016-07-06

G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer

Applicant GC America, Inc.

K-Number K153231

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GEI 2016-07-06

Voyant Fine Fusion

Applicant Applied Medical Resources

K-Number K153017

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PBQ 2016-07-06

NeuGuide

Applicant Pop Medical Solutions

K-Number K160569

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DXN 2016-07-06

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K160557

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