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

MWI 2016-06-28

MRI Patient Monitor TeslaDUO

Applicant Mipm Mammendorfer Institut Fur Physik Und Medizin

K-Number K153739

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MAX 2016-06-28

CoRoent® Ti-C System

Applicant Nu Vasive, Incorporated

K-Number K160916

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PND 2016-06-28

PowerMidline Catheter

Applicant C.R. Bard, Inc.

K-Number K153393

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MAX 2016-06-28

Nanovis Intervertebral Body Fusion System and FortiCore®

Applicant Nanovis, LLC

K-Number K160874

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NKB 2016-06-28

F1 MPS Modular Pedicle Screw System

Applicant Degen Medical

K-Number K160926

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NKB 2016-06-28

PressON Pro Spinal Fixation System

Applicant Nexus Spine, LLC

K-Number K160820

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NBZ 2016-06-28

Regular and Special Umbilical Cord Clamp and Cutter

Applicant Ningbo Feite Medical Device Co., Ltd.

K-Number K152350

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LLZ 2016-06-28

hipEOS

Applicant Onefit Medical

K-Number K161479

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NKG 2016-06-28

Gibralt® Spine System and Gibralt® Occipital Spine System

Applicant Exactech, Inc.

K-Number K160697

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FAS 2016-06-27

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

Applicant Omnitech Systems, Inc.

K-Number K151976

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FEQ 2016-06-27

EndoChoice Water Bottle Cap Irrigation System

Applicant Endochoice, Inc.

K-Number K161482

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DIO 2016-06-27

Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K161214

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