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

FRG 2017-06-23

Gemini Sterilization Wrap

Applicant Medline Industries, Inc.

K-Number K162993

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GEX 2017-06-23

HyPHo Laser System

Applicant Hyper Photonics Srl

K-Number K163449

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ODE 2017-06-22

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories

Applicant Endogastric Solutions, Inc.

K-Number K171307

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PRD 2017-06-22

FilmArray NGDS Warrior Panel

Applicant Biofire Defense, LLC

K-Number K170883

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GIM 2017-06-22

TransFix/EDTA Vacuum Blood Collection Tubes

Applicant Caltag Medsystems, Ltd.

K-Number K162723

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KTW 2017-06-22

AOS Anterolateral Proximal Humeral Plate

Applicant Advanced Orthopaedic Solutions, Inc. (Aos)

K-Number K171606

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HRS 2017-06-22

VariAx 2 Compression Plating System

Applicant Stryker GmbH

K-Number K170727

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QPB 2017-06-22

VITRUVIAN INFILTRATION PUMP

Applicant Black & Black Surgical, Inc.

K-Number K170629

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PFF 2017-06-22

Ion PGM Dx System

Applicant Life Technologies Corporation

K-Number K170299

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DZE 2017-06-22

Spiral Shape Dental Implant System

Applicant Gp Implants

K-Number K162299

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NLH 2017-06-22

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)

Applicant Innovative Health, LLC

K-Number K170922

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IYO 2017-06-22

CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

Applicant Mcube Technology Co., Ltd.

K-Number K171591

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