Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

FMI 2016-06-07

SureFine Pen Needle

Applicant Shina Med Corporation

K-Number K152877

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JZG 2016-06-07

Beta-2-Microglobulin

Applicant Beckman Coulter Ireland, Inc.

K-Number K161297

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LHC 2016-06-07

Getinge Series Warming Cabinet

Applicant Getinge Sourcing, LLC

K-Number K153713

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FPA 2016-06-07

Smart Set

Applicant Top Spins, Inc.

K-Number K151250

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EMA 2016-06-06

ORAL BOND

Applicant Steiner Laboratories

K-Number K142130

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ELL 2016-06-06

NobelProcera HT ML Full Contour Zirconia Crown

Applicant Nobel Biocare AB

K-Number K153534

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HKI 2016-06-06

MICROPERIMETER MP-3

Applicant Nidek Co., Ltd.

K-Number K152729

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LJT 2016-06-06

NMI DUAL PORT II

Applicant Navilyst Medical, Inc.

K-Number K151239

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MAX 2016-06-06

LATERAL Spine Truss System

Applicant 4Web, Inc.

K-Number K153436

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MEH 2016-06-03

Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K153131

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HWC 2016-06-03

Large Screws Range

Applicant Newclip Technics

K-Number K160617

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ECX 2016-06-03

Medipure Oxygen-LC System

Applicant Praxair Distribution, Incorporated.

K-Number K153518

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