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 2017-05-02

iGlucose Blood Glucose Monitoring System

Applicant Bionime Corporation

K-Number K161790

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OZZ 2017-05-02

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

Applicant Luminex Corporation

K-Number K163626

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KGO 2017-05-02

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

Applicant Semperit Investments Asia Pte , Ltd.

K-Number K160781

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MQV 2017-05-02

Vitoss Bioactive (BA) Injectable

Applicant Orthovita, Inc.

K-Number K163621

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NFT 2017-05-02

AssureTech Panel Dip Test, AssureTech Quick Cup Test

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K170049

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GZB 2017-05-02

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

Applicant Stimwave Technologies Incorporated

K-Number K170141

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CAF 2017-05-02

Airworks Nebulizer pe1200m

Applicant Convexity Scientific, LLC

K-Number K162041

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PCH 2017-05-02

BD MAX Extended Enteric Bacterial Panel, BD MAX System

Applicant Becton, Dickinson and Company

K-Number K170308

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EGJ 2017-05-01

IontoDC

Applicant Soterix Medical, Inc.

K-Number K170291

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MQB 2017-05-01

Televere Digital Imaging System

Applicant Televere Systems

K-Number K170975

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OLO 2017-05-01

StealthStation S8 Spine Software v1.0.0

Applicant Medtronic Navigation

K-Number K170011

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NUJ 2017-05-01

Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider

Applicant Surgical Instrument Services and Savings, Inc.

K-Number K162751

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