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

FJK 2016-02-24

Oxyless Blood Tubing Set

Applicant Oxyless, Ltd.

K-Number K150304

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DRA 2016-02-24

HeartLight Deflectable Sheath

Applicant Cardiofocus, Inc.

K-Number K152310

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JHI 2016-02-24

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

Applicant Assure Tech. Co., Ltd.

K-Number K152768

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KZA 2016-02-24

IV-eye

Applicant Novarix Limited

K-Number K152088

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FDF 2016-02-23

Fujifilm Video Colonoscope Model EC-600WL V2

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K160196

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NKB 2016-02-23

Palisade Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K153323

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DIF 2016-02-23

Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series

Applicant Biochemical Diagnostics, Inc.

K-Number K153474

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ITI 2016-02-23

twion

Applicant Alber GmbH

K-Number K151717

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LLZ 2016-02-23

FS-PACS

Applicant Ec-Web Co., Ltd.

K-Number K152034

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DQK 2016-02-23

Navik 3D

Applicant Apn Health, LLC

K-Number K152160

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DXN 2016-02-23

Spot Skan

Applicant Skanray Technologies Private Limited

K-Number K152831

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FFK 2016-02-23

UreTron MultiProbe Lithotripter System

Applicant Med-Sonics Corp.

K-Number K160198

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