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

DYB 2016-08-25

HQS Introducer (Model 2064-HQS)

Applicant Alseal

K-Number K153494

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DQY 2016-08-25

ASAHI Corsair Pro

Applicant Asahi Intecc Co., Ltd.

K-Number K161126

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PHX 2016-08-25

Integra TITAN Reverse Shoulder System

Applicant Integra LifeSciences Corporation

K-Number K161189

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MAX 2016-08-25

NuVasive Lumbar Interbody Implants

Applicant Nu Vasive, Incorporated

K-Number K161230

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LSR 2016-08-25

Anti-Borrelia burgdorferi US Westernblot (IgG)

Applicant Euroimmun US

K-Number K161513

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LOL 2016-08-25

LIAISON HAV IgM, LIAISON Control HAV IgM

Applicant DiaSorin, Inc.

K-Number K160650

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FPA 2016-08-25

LifeFlow Rapid Infusion Device (LifeFlow Device)

Applicant 410 Medical Innovation, LLC

K-Number K153731

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BTT 2016-08-25

AirLife Autofill Humidification Chamber

Applicant Carefusion 2200, Inc.

K-Number K160764

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NKB 2016-08-25

G Surgical Marksman MIS System

Applicant G Surgical, LLC

K-Number K161516

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HIS 2016-08-25

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

Applicant M3 Global Enterprises, LLC

K-Number K161195

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DXN 2016-08-25

V10

Applicant Mediana Co., Ltd.

K-Number K152659

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PJA 2016-08-24

FFRct

Applicant HeartFlow, Inc.

K-Number K161772

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