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

IPF 2018-05-23

geko T-3 Neuromuscular Stimulator

Applicant Firstkind Limited

K-Number K181059

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ODP 2018-05-23

PATRIOT COLONIAL Spacer, SUSTAIN Spacer

Applicant Globus Medical, Inc.

K-Number K173722

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HRS 2018-05-23

AlignX Ankle Fusion System

Applicant Extremity Medical, LLC

K-Number K181067

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MCW 2018-05-22

Pantheris System

Applicant Avinger, Inc.

K-Number K173862

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GXY 2018-05-22

Reusable and Self-Adhesive Electrodes

Applicant Shaoxing Dongzhi Electrical Technology Co., Ltd.

K-Number K180773

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GWG 2018-05-22

Cellvizio 100 Series Systems with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K180270

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HRS 2018-05-22

Omni Foot Plating System

Applicant Extremity Medical, LLC

K-Number K180808

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MAI 2018-05-22

Arthrex FastThread Interference Screw

Applicant Arthrex, Inc.

K-Number K180662

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GEI 2018-05-22

DiLumen Endolumenal Interventional Scissors (DiLumen Is)

Applicant Lumendi, LLC

K-Number K173405

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IYN 2018-05-22

NeuralBot

Applicant Neural Analytics, Inc.

K-Number K180455

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LJS 2018-05-21

Biowy PlCC Catheter

Applicant Biowy Corporation

K-Number K173956

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KDJ 2018-05-21

staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K173593

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