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

OWT 2020-03-26

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

Applicant Novus Scientific AB

K-Number K191749

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DQX 2020-03-26

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

Applicant Volcano Corporation

K-Number K192886

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GWM 2020-03-26

Becker External Drainage and Monitoring System

Applicant Medtronic, Inc.

K-Number K200456

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MBI 2020-03-26

Bonecam Suture Anchor

Applicant Valeris Medical, Inc.

K-Number K193108

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CAF 2020-03-26

Propeller Sensor for Symbicort

Applicant Reciprocal Labs Corporation

K-Number K192724

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PKR 2020-03-26

gammaCore Sapphire

Applicant Electrocore, Inc.

K-Number K191830

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GEX 2020-03-26

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

Applicant Ellipse A/S

K-Number K192951

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JEY 2020-03-26

Stryker Customized Mandible Recon Plate Kit

Applicant Stryker

K-Number K193136

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IYN 2020-03-26

KOSMOS

Applicant EchoNous, Inc.

K-Number K193518

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JEY 2020-03-26

Stryker Facial iD Plating System

Applicant Stryker

K-Number K193143

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QDQ 2020-03-25

MammoScreen

Applicant Therapixel

K-Number K192854

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GEX 2020-03-25

LightWalker Laser System Family

Applicant Fotona D.O.O.

K-Number K193661

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