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

LZA 2016-12-21

Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

Applicant Brightway Holdings Sdn. Bhd.

K-Number K161215

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NYL 2016-12-21

EndoVac Pure

Applicant Kerr Corporation

K-Number K162436

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ODP 2016-12-21

IMSE Cervical Cage

Applicant The Institute of Musculoskeletal Science & Education

K-Number K162003

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EIH 2016-12-21

L- OVC

Applicant Rhondium, Ltd.

K-Number K162677

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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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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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