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

MQB 2016-04-08

FDR D-EVO flat Panel Detector System

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

K-Number K153464

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LPL 2016-04-08

EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

Applicant Eyeyon Medical

K-Number K153305

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DSI 2016-04-08

Nihon Kohden Afib Detection Program QP-039P

Applicant Nihon Kohden Corporation

K-Number K152305

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DZE 2016-04-08

KLOCKNER VEGA DENTAL IMPLANT SYSTEM

Applicant SOADCO, S.L.

K-Number K153098

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OSH 2016-04-08

OLYMPIC Posterior Spinal Fixation System

Applicant Astura Medical

K-Number K153446

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IYO 2016-04-08

Bladder Scanner

Applicant Caresono Technology Co., Ltd.

K-Number K153581

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GEI 2016-04-08

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM

Applicant Teleflexmedical, Inc.

K-Number K153063

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MEA 2016-04-08

LifeCare PCA Infusion System

Applicant Hospira, Inc.

K-Number K143612

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LLZ 2016-04-08

spineEOS

Applicant Onefit Medical

K-Number K160407

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NHC 2016-04-08

VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter

Applicant Cook Incorporated

K-Number K160223

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LLZ 2016-04-08

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

Applicant Rayence Co., Ltd.

K-Number K160579

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JDR 2016-04-08

First Ray Internal Bone Staple System

Applicant First Ray, LLC

K-Number K153622

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