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

GEI 2016-12-21

NICO Myriad

Applicant Nico Corporation

K-Number K161307

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GXZ 2016-12-21

DMS Disposable Subdermal Needle Electrodes

Applicant Daehan Medical Systems Co., Ltd.

K-Number K161566

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ESW 2016-12-21

Evolution Esophageal Stent System Partially Covered

Applicant Cook Ireland, Ltd.

K-Number K162717

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NLH 2016-12-21

Reprocessed Viking Diagnostic Electrophysiology Catheters

Applicant Innovative Health, LLC

K-Number K162251

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KRO 2016-12-21

GMK Revision Femoral Distal Augmentation

Applicant Medacta International S.A.

K-Number K163311

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PPW 2016-12-21

CipherOx CRI Tablet

Applicant Flashback Technologies, Inc.

K-Number DEN160020

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DRG 2016-12-21

TelePatch Cardiac Monitor

Applicant Medicomp, Inc.

K-Number K161916

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HRS 2016-12-21

VLP MINI-MOD 2.0mm Column Plates

Applicant Smith & Nephew, Inc.

K-Number K163086

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LYZ 2016-12-21

DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Zibo Daiyang Plastic Company

K-Number K162259

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PLP 2016-12-21

Sonablate

Applicant Sonacare Medical, LLC

K-Number K160942

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MCW 2016-12-21

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

Applicant Avinger, Inc.

K-Number K163264

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OCC 2016-12-21

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

Applicant Alere Scarborough, Inc.

K-Number K163266

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