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

LYZ 2018-03-09

Powder-free Clear Vinyl Patient Examination Gloves

Applicant Yongsheng Medical Products Co., Ltd.

K-Number K173078

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FTL 2018-03-09

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)

Applicant Sofradim Production

K-Number K173796

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KWT 2018-03-09

Catalyst CSR 3 Peg Glenoids

Applicant Catalyst Orthoscience, Inc.

K-Number K173812

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LLZ 2018-03-09

BrightMatter Plan 1.6.0

Applicant Synaptive Medical, Inc.

K-Number K180394

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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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