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

FXX 2021-03-02

Surgical Mask-Model Number: Ear Loop, Flat-Pleated

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K201852

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NAY 2021-03-02

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K202166

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IYN 2021-03-02

SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K201965

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KRO 2021-03-02

GMK Revision & Hinge Extension - TiNbN Coating

Applicant Medacta International S.A.

K-Number K210010

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OTK 2021-03-02

PleuraFlow System with FlowGlide

Applicant Clearflow, Inc.

K-Number K203394

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MQB 2021-03-02

Mars1717X Wireless Digital Flat Panel Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K210314

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FXX 2021-03-02

IFM Surgical Mask Model SM3

Applicant Fssc, LLC

K-Number K202214

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JAK 2021-03-02

MaxFOV 2

Applicant Ge Medical Systems, LLC

K-Number K203617

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CAW 2021-03-02

X-PLO2R

Applicant Belluscura, LLC

K-Number K203086

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ONB 2021-03-02

Arisure Closed System Drug Transfer Device (CSTD)

Applicant Yukon Medical, LLC

K-Number K201422

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HRS 2021-03-02

Able Medical Devices Valkyrie Thoracic Fixation System

Applicant Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices

K-Number K202889

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LZA 2021-03-02

Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)

Applicant Kanglongda Vietnam Protection Technology Company Limited

K-Number K202356

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