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

OOI 2016-06-30

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

Applicant Luminex Corporation

K-Number K161495

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PJJ 2016-06-30

STERIZONE Sterilizer

Applicant Tso3, Inc.

K-Number K153689

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FTC 2016-06-30

3 Series Phototherapy Unit

Applicant Daavlin Distributing Company

K-Number K153749

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LNH 2016-06-30

RTHawk, HeartVista Cardiac Package

Applicant Heartvista, Inc.

K-Number K153740

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EIH 2016-06-30

Initial LiSi Press

Applicant GC America, Inc.

K-Number K153136

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JJX 2016-06-30

LIAISON CMV IgM Serum Control Set

Applicant DiaSorin, Inc.

K-Number K161526

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FOZ 2016-06-30

ViaValve Safety I.V. Catheter

Applicant Smiths Medical Asd, Inc.

K-Number K160235

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NHA 2016-06-30

VITA ENAMIC Implant Solutions (IS)

Applicant Vita Zahnfabrik H.Rauter GmbH Co.

K-Number K153645

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OZE 2016-06-30

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

Applicant Centers For Disease Control and Prevention (CDC)

K-Number K161556

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JJX 2016-06-30

LIAISON EBV IgM Serum Control Set

Applicant DiaSorin, Inc.

K-Number K161522

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NUC 2016-06-30

Repagyn vaginal suppositories

Applicant Farma-Derma S.R.L.

K-Number K153372

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ELW 2016-06-30

Identic and KromaFaze Alginate Dental Impression Materials

Applicant Kerr Corporation

K-Number K160441

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