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

IYN 2016-08-05

Vivid iq

Applicant Ge Medical Systems Ultrasound and Primary Care Diagnostics L

K-Number K161706

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MED 2016-08-05

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K-Number K161683

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HAE 2016-08-04

Fehling-Punches

Applicant Fehling Instruments GmbH & Co. KG

K-Number K153243

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DQY 2016-08-04

SIDEKICK and USHER Support Catheters

Applicant Bard Peripheral Vascular, Inc.

K-Number K161986

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LZA 2016-08-04

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

Applicant Hartalega Sdn Bhd

K-Number K160560

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NPL 2016-08-04

OSSIX PLUS

Applicant Datum Dental, Ltd.

K-Number K160281

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DXN 2016-08-04

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K160563

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NPL 2016-08-04

OSSIX VOLUMAX

Applicant Datum Dental, Ltd.

K-Number K153549

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LYY 2016-08-04

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

Applicant Hartalega Sdn Bhd

K-Number K161006

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MMK 2016-08-04

Med-Tainer Single Deposit Container

Applicant Snyder Industries, Inc.

K-Number K153274

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LYY 2016-08-04

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Applicant A1 Glove Sdn Bhd

K-Number K153744

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NKB 2016-08-04

Mont Blanc and Mont Blanc MIS Spinal Systems

Applicant Spineway SA

K-Number K161387

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