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

MNH 2016-08-30

ANAX 5.5 Spinal System

Applicant U&I Corporation

K-Number K162189

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FRN 2016-08-30

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

Applicant Zyno Medical, LLC

K-Number K153193

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DKZ 2016-08-30

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K161251

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OUY 2016-08-29

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

Applicant Cepheid

K-Number K161619

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FLL 2016-08-29

Digital Thermometer

Applicant Biocare Asia Corporation , Ltd.

K-Number K161211

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FOZ 2016-08-29

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K161777

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OVD 2016-08-29

INDEPENDENCE MIS Spacers

Applicant Globus Medical, Inc.

K-Number K160597

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KWS 2016-08-29

Arthrex VaultLock Glenoid

Applicant Arthrex, Inc.

K-Number K161108

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OMP 2016-08-29

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large

Applicant Lc Medical Concepts, Inc.

K-Number K161570

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FRO 2016-08-29

USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles

Applicant Strukmyer Medical, LLC

K-Number K161311

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NHA 2016-08-29

ATLANTIS Abutment for HIOSSEN ET implant

Applicant Dentsply Sirona

K-Number K160626

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FMI 2016-08-29

Insulin Pen Needle

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K153706

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