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

GXY 2016-03-21

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

Applicant Bio Protech, Inc.

K-Number K153019

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KPS 2016-03-21

D-SPECT Processing and Reviewing Workstation

Applicant Spectrum Dynamics , Ltd.

K-Number K160120

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ONF 2016-03-21

Venus Versa System

Applicant Venus Concept , Ltd.

K-Number K153717

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IYO 2016-03-21

SpeqT

Applicant Signostics Limited

K-Number K160420

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JDR 2016-03-21

OS2(R)-VP Varisation Staple

Applicant In2bones Sas

K-Number K153770

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FCG 2016-03-21

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle

Applicant Cook Ireland, Ltd.

K-Number K160229

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LRK 2016-03-21

Oniris

Applicant Sas Oniris

K-Number K150566

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MPO 2016-03-18

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

Applicant CooperSurgical, Inc.

K-Number K151845

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GEI 2016-03-18

SPINAUT-P

Applicant Imedicom Co., Ltd.

K-Number K150915

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LAF 2016-03-18

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Applicant Immunalysis Corporation

K-Number K153693

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JAK 2016-03-18

somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K151749

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ONX 2016-03-18

OVA1 Next Generation

Applicant Vermillion, Inc.

K-Number K150588

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