Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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

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

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K173593

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PEK 2018-05-21

AERIAL™ Interspinous Fixation

Applicant Globus Medical, Inc.

K-Number K180817

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NHN 2018-05-21

Erchonia FX-635

Applicant Erchonia Corporation

K-Number K180197

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NKB 2018-05-21

SAGICO OSI Spinal System by Osimplant

Applicant Spinal Analytics & Geometrical Implant Co, LLC

K-Number K180220

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JAA 2018-05-21

MECALL CLISIS SYSTEMS, Discovery RF180

Applicant General Medical Merate S.P.A

K-Number K173395

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FDI 2018-05-21

Polypectomy Snare

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K172729

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FMI 2018-05-21

VACUETTE SAFELINK Holder with male luer lock

Applicant Greiner Bio-One Na, Inc.

K-Number K180545

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QBW 2018-05-18

VESTEX Apparel

Applicant Vestagen Protective Technologies, Inc.

K-Number K180217

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PGZ 2018-05-18

XSTAT 30, 1-Pack

Applicant Revmedx, Inc.

K-Number K180051

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