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

OCC 2016-08-02

ARIES® Flu A/B & RSV Assay

Applicant Luminex Corporation

K-Number K161220

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CBI 2016-08-02

5.0 Fr Arndt Endobronchial Blocker Set

Applicant Cook Incorporated

K-Number K160542

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LYZ 2016-08-02

Powder free vinyl patient examination glove, colored (yellow)

Applicant Kaixing Plastic Products Co., Litd.

K-Number K160675

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LZA 2016-08-02

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

Applicant Kossan International Sdn Bhd

K-Number K151824

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MAX 2016-08-01

VIRTU Lumbar Spacer System

Applicant Met 1 Technologies, LLC

K-Number K160699

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PON 2016-08-01

Aqueduct 100 Cervical Dilator

Applicant Gtimd, LLC

K-Number K160664

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PEA 2016-08-01

Fuse Endoscopic System with FuseBox Processor

Applicant Endochoice, Inc.

K-Number K160275

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MOS 2016-08-01

8ch Foot Ankle Coil

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K160932

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ODA 2016-08-01

IDSS ForceTriad Control Module

Applicant Black Diamond Video, Inc.

K-Number K153205

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ITX 2016-08-01

Precision Point Biopsy Needle Guide

Applicant Corbin Clinical Resources, LLC

K-Number K160414

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LLZ 2016-08-01

Senolris

Applicant GE Healthcare

K-Number K160937

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MAX 2016-08-01

SpineView X-Pac Expandable Lumbar Cage System

Applicant Spine View, Inc.

K-Number K160856

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