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

NJR 2016-12-23

ARIES GBS Assay

Applicant Luminex Corporation

K-Number K162772

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PIJ 2016-12-23

XenMatrix AB Surgical Graft

Applicant C. R. Bard

K-Number K162193

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JOW 2016-12-23

Reprocessed Kendall SCD Express Foot Cuff

Applicant Covidien

K-Number K163055

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DQY 2016-12-23

AMPLATZER TorqVue 45x45 Delivery Sheath

Applicant Aga Medical COrporation (Wholly Owned by St. Jude Medical CO

K-Number K163000

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LLZ 2016-12-23

Ez3D-i / E3

Applicant Ewoosoft Co., Ltd.

K-Number K163539

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JKA 2016-12-23

Kurin Blood Culture Collection Set

Applicant Pathway, LLC

K-Number K162233

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NHN 2016-12-22

Collagentex Rx-1

Applicant Tanses Technologies, Inc.

K-Number K162022

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JPK 2016-12-22

XN CHECK BF

Applicant Streck

K-Number K160588

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LJS 2016-12-22

VPS Rhythm Device with TipTracker Technology

Applicant Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)

K-Number K160925

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MPN 2016-12-22

derma+flex QS High Viscosity Tissue Adhesive

Applicant Chemence Medical, Inc.

K-Number K162352

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KWQ 2016-12-22

Sphynx™

Applicant Eden Spine, LLC

K-Number K160982

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NHV 2016-12-22

HydraGuard 10 UltraFilter

Applicant Nephros, Inc.

K-Number K161467

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