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

MUH 2018-06-20

Televere Digital Dental Imaging System

Applicant Televere Systems, Inc.

K-Number K181358

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FDS 2018-06-20

Visura Technologies TEECAD System

Applicant Visura Technologies, LLC

K-Number K180911

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JWH 2018-06-20

Balanced Knee Revision System - Offset Junction Box

Applicant Ortho Development Corporation

K-Number K180743

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CCK 2018-06-20

SuperNO2VA Et Device

Applicant Revolutionary Medical Devices, Inc.

K-Number K173147

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NGZ 2018-06-20

VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

Applicant bioMerieux, Inc.

K-Number K181368

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QBO 2018-06-20

Cartiva SCI Disposable Instrumentation Set

Applicant Cartiva, Inc.

K-Number K181348

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LXM 2018-06-20

Atlas Percussion Adjusting Instrument

Applicant Spinalight, Inc.

K-Number K172536

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EBW 2018-06-19

Surgic Pro, Surgic Pro+

Applicant Nakanishi, Inc.

K-Number K173905

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NLH 2018-06-19

Reprocessed DecaNav Diagnostic Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K180710

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LLZ 2018-06-19

sterEOS Workstation

Applicant Eos Imaging

K-Number K172346

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OLP 2018-06-19

Neutrogena Light Therapy Acne Mask+

Applicant Johnson & Johnson Consumer, Inc.

K-Number K180847

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NBW 2018-06-19

Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

Applicant Bionime Corporation

K-Number K173139

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