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

FRN 2019-06-07

Ivenix Infusion System (IIS)

Applicant Ivenix, Inc.

K-Number K183311

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MUD 2019-06-07

Masimo O3 Regional Oximeter System

Applicant Masimo Corporation

K-Number K182429

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NGX 2019-06-07

Miha Bodytec II

Applicant Miha Bodytec GmbH

K-Number K182519

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DRF 2019-06-07

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

Applicant Baylis Medical Company, Inc.

K-Number K183649

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LRK 2019-06-07

TD Clip

Applicant Zephyr Sleep Technologies, Inc.

K-Number K190051

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ELC 2019-06-07

tün® ultrasonic tips product family

Applicant Engineered Endodontics

K-Number K182145

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HRS 2019-06-07

RIVAL View Plating Systems and Reduce Fracture Plating Systems

Applicant Orthofix Srl

K-Number K190388

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NXC 2019-06-07

Argen Clear Aligner

Applicant Argen Corporation

K-Number K183229

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NJM 2019-06-07

Ceramic Bracket

Applicant Mem Dental Technology Co., Ltd.

K-Number K180952

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DRG 2019-06-07

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20

Applicant Vitalconnect, Inc.

K-Number K190916

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CIX 2019-06-07

VITROS XT Chemistry Products ALB-TP Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K191316

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LPH 2019-06-07

DJO Acetabular System

Applicant Encore Medical L.P.

K-Number K190057

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