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

GEI 2020-04-01

Venus VivaTM

Applicant Venus Concept USA, Inc.

K-Number K191065

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KGO 2020-04-01

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use

Applicant Medline Industries, Inc.

K-Number K192988

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DZE 2020-04-01

DSI Dental Implant System

Applicant Dsi Dental Solutions, Ltd.

K-Number K200188

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MQB 2020-04-01

Focus 43C detector, TRIMAX 43C detector

Applicant Iray Technology Taicang , Ltd.

K-Number K200622

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ONN 2020-04-01

VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left

Applicant Orthosensor, Inc.

K-Number K193580

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FOZ 2020-04-01

Introcan Safety 2 IV Catheter 18-24 gauge

Applicant B.Braun Medical, Inc.

K-Number K192676

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PNL 2020-04-01

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K191762

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QAS 2020-03-31

Rapid ICH

Applicant Ischemaview Incorporated

K-Number K193087

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DXC 2020-03-31

SiteSeal Femoral Compression Device

Applicant Ensite Vacular, LLC

K-Number K192413

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KNW 2020-03-31

CytoCore

Applicant Praxis Medical, LLC

K-Number K200278

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KDI 2020-03-31

Tablo Hemodialysis System

Applicant Outset Medical, Inc.

K-Number K200741

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GWQ 2020-03-31

iCEWav Neuromonitoring Platform

Applicant Ice Neurosystems, Inc.

K-Number K191868

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