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

LLZ 2019-09-26

StoneChecker

Applicant Imaging Biometrics, LLC

K-Number K191530

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HSB 2019-09-26

PRECICE System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K191336

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IZL 2019-09-25

PhoeniX

Applicant Sedecal., Sa.

K-Number K192011

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IYE 2019-09-25

Thermoplastic Masks

Applicant Aktina Medical Corporation

K-Number K192102

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MAX 2019-09-25

TranS1 Interbody Fusion System

Applicant Trans1

K-Number K191791

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MWI 2019-09-25

LifeWindow LW8 Lite

Applicant Digicare Biomedical Technology, Inc.

K-Number K183687

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NQX 2019-09-25

ARIES MRSA Assay

Applicant Luminex Corporation

K-Number K191742

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JXE 2019-09-25

Mediracer NCS

Applicant Mediracer OY

K-Number K190536

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POD 2019-09-25

NuStat

Applicant Beeken Biomedical, LLC

K-Number K183190

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GCJ 2019-09-25

3D Visualization System

Applicant Scivita Medical Technology Co., Ltd.

K-Number K183675

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CAH 2019-09-25

SafeBreath Filter Mouthpiece

Applicant MD Diagnostics Limited

K-Number K190022

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HQC 2019-09-25

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)

Applicant D.O.R.C. Dutch Ophthalmic Research Center (International)

K-Number K190875

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