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

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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CAF 2019-06-07

Hailie Sensor

Applicant Adherium (Nz), Ltd.

K-Number K182573

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BZG 2019-06-06

ComPAS2 (Computerized Pulmonary Analysis System)

Applicant Morgan Scientific, Inc.

K-Number K190568

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HRS 2019-06-06

PROSTEP TBC Implant System

Applicant Wrightmedicaltechnologyinc

K-Number K183620

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OVD 2019-06-06

Idys ALIF TiVac

Applicant Clariance, Sas

K-Number K191263

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LON 2019-06-06

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

Applicant bioMerieux, Inc.

K-Number K190616

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HIH 2019-06-06

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K-Number K191335

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ODP 2019-06-06

RIGEL PEEK Anterior Cervical Interbody Fusion System

Applicant MiRus, LLC

K-Number K190618

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