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

MAX 2016-08-19

Valeo II Interbody Fusion Device System

Applicant Amedica Corp.

K-Number K161405

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CCT 2016-08-19

MADgic Laryngo-Tracheal Mucosal Atomization Device

Applicant Teleflex Medical

K-Number K153470

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DQO 2016-08-19

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak

Applicant Medtronic Vascular

K-Number K161287

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GWM 2016-08-19

Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

Applicant Codman & Shurtleff, Inc.

K-Number K153347

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LDF 2016-08-19

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K-Number K161249

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ODR 2016-08-19

Electrosurgical disposable grounding pads

Applicant Top-Rank Health Care Co., Ltd.

K-Number K160366

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OXE 2016-08-19

Kerecis SecureMesh

Applicant Kerecis Limited

K-Number K153364

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MEG 2016-08-19

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle

Applicant Sol-Millennium Medical, Inc.

K-Number K162030

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NBW 2016-08-19

Wireless Smart Gluco-Monitoring System

Applicant Andon Health Co, Ltd.

K-Number K153278

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PBX 2016-08-19

InMode System MiniFX Handpiece

Applicant Inmode MD , Ltd.

K-Number K160329

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KRA 2016-08-18

Bullfrog Micro-Infusion Device

Applicant Mercator Medsystems, Inc.

K-Number K161402

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FPA 2016-08-18

PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

Applicant C.R. Bard, Inc.

K-Number K153440

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