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

LIT 2016-07-29

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K160256

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JSM 2016-07-29

Puritan Opti-Tranz Cary-Blair Collection and Transport System

Applicant Puritan Medical Products, LLC

K-Number K160082

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KRA 2016-07-29

CrossCath Support Catheter

Applicant Cook Incorporated

K-Number K161801

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NKB 2016-07-29

VertiForm Posterior Fixation System

Applicant Next Orthosurgical

K-Number K161499

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NBW 2016-07-29

UniStrip1 Generic Blood Glucose Test Strips

Applicant Ok Biotech Co., Ltd.

K-Number K160038

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HWC 2016-07-29

Cannulated Screw

Applicant Miami Device Solutions, LLC

K-Number K161058

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EMA 2016-07-29

TheraCem

Applicant Bisco, Inc.

K-Number K161256

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LZA 2016-07-29

Powder Free Blue Nitrile Examination Glove

Applicant Qube Medical Product Sdn Bhd

K-Number K153732

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PDW 2016-07-29

Cianna Medical SAVI Scout Reflector and SAVI Scout System

Applicant Cianna Medical, Inc.

K-Number K161507

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NDN 2016-07-29

MEDINAUT Kyphoplasty System

Applicant Imedicom Co., Ltd.

K-Number K153296

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GEI 2016-07-29

Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating

Applicant Bovie Medical Corporation

K-Number K161558

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DXT 2016-07-29

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

Applicant Merit Medical Systems, Inc.

K-Number K160107

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