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

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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OHS 2016-07-29

Bright

Applicant Tanda Beauty Canada, Inc.

K-Number K161849

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NKB 2016-07-29

PASS LP Spinal System

Applicant Medicrea International SA

K-Number K161627

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IYN 2016-07-28

ACUSON NX2 Diagnostic Ultrasound Systems

Applicant Siemens Medical Solutions USA, Inc.

K-Number K161787

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DGC 2016-07-28

ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls

Applicant Phadia AB

K-Number K161899

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