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

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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JWH 2019-09-25

OMNI TiN Coated Apex Knee™ System

Applicant Omni Life Science, Inc.

K-Number K191765

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NUC 2019-09-25

Aloe Glide Lubricant

Applicant Desert Harvest, Inc.

K-Number K190323

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NXO 2019-09-24

Buhlmann fCAL turbo and CALEX Cap

Applicant Buhlmann Laboratories AG

K-Number K191718

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OLO 2019-09-24

Mako Total Hip Application, Mako Total Knee Application

Applicant Mako Surgical Corp.

K-Number K191998

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