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

LNH 2016-09-01

SIGNA Voyager

Applicant GE Healthcare

K-Number K161567

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KTI 2016-09-01

Elation Pulmonary Balloon Dilation

Applicant Merit Medical Systems, Inc.

K-Number K161392

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EHD 2016-09-01

EzRay Air (Model VEX-P300)

Applicant VATECH Co., Ltd.

K-Number K161063

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KIF 2016-09-01

MTA2.2 MATERIAL

Applicant Avalon Biomed, Inc.

K-Number K161239

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EIH 2016-09-01

XP202

Applicant 3M Deutschland GmbH

K-Number K161922

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OMP 2016-08-31

RENASYS-G Gauze Dressing Kits with Soft Port

Applicant Smith & Nephew, Inc.

K-Number K162129

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HCG 2016-08-31

HydroCoil Embolic System (HES)

Applicant MicroVention, Inc.

K-Number K161367

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IYN 2016-08-31

Vscan Extend

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K161588

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NBW 2016-08-31

ACCU-CHEK Guide Blood Glucose Monitoring System

Applicant Roche Diabetes Care, Inc.

K-Number K160944

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LNH 2016-08-31

MAGiC

Applicant Ge Medical Systems, LLC

K-Number K161397

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MOS 2016-08-31

1.5T and 3.0T 16 CH GE Shoulder Coils

Applicant Invivo Corporation

K-Number K162001

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MEH 2016-08-31

Exactech® Novation® Element Press-fit Femoral Stem

Applicant Exactech, Inc.

K-Number K153649

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