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

MQV 2018-12-20

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute

Applicant Prosidyan, Inc.

K-Number K182670

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FMI 2018-12-20

BD Contoured Base Pen Needle

Applicant Becton, Dickinson and Company

K-Number K182320

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MCW 2018-12-20

Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K-Number K182972

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POS 2018-12-20

Embrace

Applicant Empatica S.r.l.

K-Number K181861

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LLZ 2018-12-20

3DIEMME RealGUIDE

Applicant 3Diemme , Ltd.

K-Number K173041

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PAM 2018-12-20

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

Applicant Genmark Diagnostics, Incorporated

K-Number K181663

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DQY 2018-12-20

ASAHI Corsair Pro XS

Applicant Asahi Intecc Co., Ltd.

K-Number K182420

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JWY 2018-12-20

MTS Levofloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K183115

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NUC 2018-12-20

Natureplex Warm Touch Warming Jelly

Applicant Natureplex, LLC

K-Number K180828

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LRC 2018-12-20

Sinusway Dilation System

Applicant 3nt Medical , Ltd.

K-Number K181838

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DXT 2018-12-20

DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System

Applicant Osprey Medical, Inc.

K-Number K183267

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IYN 2018-12-20

Color Doppler Ultrasound System; Model: mEye1 and mEye2

Applicant Shenzhen Well.D Medical Electronics Co., Ltd.

K-Number K182165

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