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

NDN 2021-10-28

TRACKER Plus Kyphoplasty System

Applicant GS Medical Co., Ltd.

K-Number K211797

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LON 2021-10-28

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

Applicant bioMerieux, Inc.

K-Number K210287

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FTM 2021-10-27

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

Applicant Synovis Life Technologies. Inc. (A Subsidiary of Baxter

K-Number K213125

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LZA 2021-10-27

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K211604

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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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