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

HKY 2018-03-09

CATS Tonometer Prism

Applicant Cats Tonometer, LLC

K-Number K173904

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FGE 2018-03-09

Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set

Applicant Cook Ireland, Ltd.

K-Number K172057

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MNR 2018-03-09

Positional Sleep Assessment System (PoSAS) software

Applicant Advanced Brain Monitoring

K-Number K172799

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DQX 2018-03-09

Fixed Core Wire Guides

Applicant Cook Incorporated

K-Number K171764

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JWH 2018-03-09

Klassic® Knee System

Applicant Total Joint Orthopedics, Inc.

K-Number K180159

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FLE 2018-03-09

Amsco Evolution Medium Steam Sterilizer

Applicant STERIS Corporation

K-Number K173481

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NEU 2018-03-09

UltraCor Twirl Breast Tissue Marker

Applicant Bard Peripheral Vascular, Inc.

K-Number K180061

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PKC 2018-03-09

Exactech Equinoxe Stemless Shoulder

Applicant Exactech, Inc.

K-Number K173388

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DYB 2018-03-09

Transjugular Liver Access Sets

Applicant Cook Incorporated

K-Number K171820

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OMP 2018-03-09

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System

Applicant Kci USA, Inc.

K-Number K173426

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GZI 2018-03-09

L300 Go System

Applicant Bioness, Inc.

K-Number K173682

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LLZ 2018-03-09

Quantib Brain

Applicant Quantib B.V.

K-Number K173939

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