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

JAK 2018-03-30

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173637

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DQX 2018-03-30

Mandril Wire Guide

Applicant Cook Incorporated

K-Number K171997

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KWS 2018-03-29

Arthrex Shoulder System

Applicant Arthrex, Inc.

K-Number K171841

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OVD 2018-03-29

Arco-SA Lumbar Cage System

Applicant Neurostructures, Inc.

K-Number K173082

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DXX 2018-03-29

CorPath GRX System

Applicant Corindus, Inc.

K-Number K180517

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GAT 2018-03-29

NovoStitch Pro Meniscal Repair System

Applicant Ceterix Orthopaedics, Inc.

K-Number K180531

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DQY 2018-03-29

NaviCross 0.018

Applicant Terumo Corporation

K-Number K173799

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JOQ 2018-03-29

Bloom2 Programmable Electrophysiology Stimulator

Applicant Fischer Medical

K-Number K173439

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JHI 2018-03-29

Atellica IM Total hCG (ThCG)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K172322

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HRS 2018-03-29

IXOS Radius Plate System

Applicant Stuckenbrock Medizintechnik GmbH

K-Number K171624

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DTZ 2018-03-29

Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

Applicant Terumo Cardiovascular Systems Corporation

K-Number K172071

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EZL 2018-03-29

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter

Applicant Poiesis Medical, LLC

K-Number K173533

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