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

JPA 2016-12-12

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K162420

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GDW 2016-12-12

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

Applicant Shinemed, LLC

K-Number K160969

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GEI 2016-12-12

PK AIM

Applicant Gyrus Acmi, Inc.

K-Number K163373

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HIF 2016-12-12

U-Blade Veress Needle

Applicant Tianjin Uwell Medical Device Manufacturing Co., Ltd.

K-Number K162648

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LBI 2016-12-12

neoBLUE compact LED Phototherapy System

Applicant Natus Medical Incorporated

K-Number K160745

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GEX 2016-12-12

Photon, Photon Plus

Applicant Zolar Technology & Mfg Co., Inc.

K-Number K162114

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FYA 2016-12-12

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

Applicant Gri Medical & Electrical Technology Co., Ltd.

K-Number K162442

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IZL 2016-12-12

UC-5000 Mobile X-Ray

Applicant Source-Ray, Inc.

K-Number K163063

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IYE 2016-12-12

Varian High Energy Linear Accelerator

Applicant Varian Medical Systems, Inc.

K-Number K162476

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DAP 2016-12-10

STA® - Liatest® D-Di

Applicant Diagnostica Stago

K-Number K162227

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HRS 2016-12-09

Medline UNITE® Ankle Fracture Plating System

Applicant Medline Industries, Inc.

K-Number K162829

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OMP 2016-12-09

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System

Applicant Kci USA, Inc.

K-Number K160487

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