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

LZA 2021-07-28

Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors

Applicant Shen Wei USA, Inc.

K-Number K211455

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OHT 2021-07-28

Braun Silk.expert Mini

Applicant Cyden Limited

K-Number K211994

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PLV 2021-07-28

Neocis Guidance System (NGS) with Intraoral Fiducial Array

Applicant Neocis, Inc.

K-Number K211129

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FXX 2021-07-28

Disposable Surgical Face Mask

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K210409

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FMI 2021-07-28

NIO-I

Applicant Einstein Works, LLC

K-Number K211395

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GXY 2021-07-28

Electrode Market Disposable Surface Electrodes

Applicant Electrode Market Co., Ltd.

K-Number K211839

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DTK 2021-07-28

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

Applicant William Cook Europe Aps

K-Number K211874

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GEX 2021-07-28

Diode Laser Machine, Model Number: BM-100

Applicant Zhengzhou Bestview ST Co., Ltd.

K-Number K211335

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EOQ 2021-07-28

Broncho Videoscope System

Applicant Scivita Medical Technology Co., Ltd.

K-Number K210379

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PHX 2021-07-28

Catalyst R1 Reverse Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K211991

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FMF 2021-07-28

BD Flu+ Syringe

Applicant Becton, Dickinson and Company

K-Number K203359

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FLL 2021-07-28

Disposable Ear Thermometer Probe Cover

Applicant Huaian Zhongxin Packing Material Co., Ltd.

K-Number K203431

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