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

BTR 2020-02-14

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

Applicant Venner Medical (Singapore) Pte, Ltd.

K-Number K192120

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LLZ 2020-02-14

ASCEND Image Viewer

Applicant Ascend Hit

K-Number K192372

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NEZ 2020-02-14

CapsoCam Plus (SV-3) Capsule Endoscopy System

Applicant CapsoVision, Inc.

K-Number K192662

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KPS 2020-02-14

CardIQ Flow

Applicant GE Medical Systems SCS

K-Number K192277

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MQB 2020-02-14

E-COM DR-2000 DR

Applicant Livermoretech, Inc.

K-Number K193644

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KPS 2020-02-14

Biograph Vision, Biograph mCT Family of PET/CTs

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193248

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GYC 2020-02-14

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Applicant Blackrock Microsystems

K-Number K191346

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OLY 2020-02-14

Orion LifeSpan MEG

Applicant Compumedics Limited

K-Number K191785

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MBI 2020-02-14

Dunamis PunchTac Suture Anchors

Applicant Dunamis, LLC

K-Number K193245

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LLZ 2020-02-14

Vitrea Software Package

Applicant Canon Medical Systems Corporation

K-Number K192923

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LON 2020-02-14

VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)

Applicant bioMerieux, Inc.

K-Number K193567

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NBW 2020-02-14

OneTouch Verio Reflect Blood Glucose Monitoring System

Applicant Lifescan Europe GmbH

K-Number K193475

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