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

LZA 2018-02-22

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)

Applicant Koon Seng Sdn Bhd

K-Number K171171

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FLE 2018-02-22

Amsco Evolution Medium Steam Sterilizer

Applicant STERIS Corporation

K-Number K173485

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GWQ 2018-02-22

Natus Quantum

Applicant Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)

K-Number K180181

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DTK 2018-02-22

Sentry IVC Filter

Applicant Novate Medical , Ltd.

K-Number K173236

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JOJ 2018-02-22

U&U Indicator tape and strip

Applicant U&U Medical Technology Co, Ltd.

K-Number K171823

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GEX 2018-02-22

LightForce LTS Model 1000, 1500, 2500, and 4000

Applicant Litecure, LLC

K-Number K173067

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LJS 2018-02-22

Silicone Peripherally Inserted Central Venous Catheter Set/Tray

Applicant Cook Incorporated

K-Number K171994

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HRS 2018-02-22

Osteotomy Truss System (OTS)

Applicant 4Web, Inc.

K-Number K172294

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LRK 2018-02-22

The Panthera Anti-Snoring X3 Device

Applicant Panthera Dental, Inc.

K-Number K171576

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DXJ 2018-02-22

Nexxis OR

Applicant Barco N.V.

K-Number K173381

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HSB 2018-02-22

Talon DistalFix Humeral Nail

Applicant Orthopedic Designs North America, Inc.

K-Number K173255

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NHA 2018-02-22

Straumann CARES M-Series CAD/CAM System

Applicant Institut Straumann AG

K-Number K171649

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