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

GEI 2020-06-26

Venus Viva MD Device

Applicant Venus Concept USA, Inc.

K-Number K201164

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KPR 2020-06-26

DRX-Compass

Applicant Carestream Health, Inc.

K-Number K201373

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DHB 2020-06-26

NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense

Applicant Hycor Biomedical

K-Number K200825

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OLO 2020-06-26

Streamline Navigated Instruments

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K-Number K200095

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QSX 2020-06-26

D-Stat Radial Topical Hemostat

Applicant Vascular Solutions, LLC

K-Number K200720

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LLZ 2020-06-26

Optimized Positioning System (OPS) ReView

Applicant Corin USA

K-Number K193042

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GEX 2020-06-26

Stardust Med

Applicant I.T.S. Group S.R.L.

K-Number K200736

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PGW 2020-06-26

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

Applicant Medtronic Navigation, Inc.

K-Number K200723

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EOQ 2020-06-26

Ion Endoluminal System

Applicant Intuitive Surgical, Inc.

K-Number K201146

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LBH 2020-06-25

FiteBac Antimicrobial Cavity Cleanser

Applicant Largent Health, LLC

K-Number K200614

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MQK 2020-06-25

VitriGuard

Applicant Origio A/S

K-Number K200815

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DZE 2020-06-25

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K192221

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