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

OMP 2021-10-27

V.A.C.ULTA Negative Pressure Wound Therapy System

Applicant Kci, A Part of 3M Health Care Business Group

K-Number K203316

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GEI 2021-10-27

The Alma Opus System, Colibri Applicator and Tips

Applicant Alma Lasers, Inc.

K-Number K201520

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JTN 2021-10-27

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K210873

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LYA 2021-10-27

SPIWay Endonasal Access Guide

Applicant Spiway, LLC

K-Number K213153

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LZA 2021-10-26

Disposable Medical Nitrile Examination Gloves

Applicant Lanhuo Medical Technology (Jiangsu) Co.,Ltd

K-Number K212363

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IZF 2021-10-26

CLISIS SYSTEMS, Discovery RF180

Applicant General Medical Merate S.P.A

K-Number K213081

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LPL 2021-10-26

Avaira Vitality

Applicant CooperVision, Inc.

K-Number K213164

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GEX 2021-10-26

Vydence Zye and Vydence One

Applicant Vydence Medical Industria E Comercio Ltda

K-Number K202998

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GEX 2021-10-26

Medical Diode Laser Systems

Applicant Wuhan Dimed Laser Technology Co., Ltd.

K-Number K211977

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QEZ 2021-10-26

Thrombuster II Aspiration Catheter

Applicant Kaneka Medical America, LLC

K-Number K213166

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NXC 2021-10-26

QuickAligners

Applicant Oral Image, Inc.

K-Number K211537

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PHX 2021-10-26

Tomier Perform Reversed Glenoid Cannulated Glenospheres

Applicant Tornier, Inc.

K-Number K213124

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