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

ITI 2021-07-09

Extreme X8

Applicant Magic Mobility

K-Number K211574

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MJN 2021-07-09

AortaSTAT Occlusion Device

Applicant Renalpro Medical, Inc.

K-Number K210602

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KGO 2021-07-09

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs

Applicant Gx Corporation Sdn Bhd

K-Number K200915

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NEY 2021-07-09

Microwave Therapeutic System

Applicant Nanjing Eco Microwave System Co., Ltd.

K-Number K201262

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HRS 2021-07-09

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

Applicant Truemed Group, LLC

K-Number K200575

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QAS 2021-07-08

HALO

Applicant Nicolab B.V.

K-Number K211788

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FXX 2021-07-08

Medical surgical mask

Applicant Shantou T&K Medical Equipment Factory Co.,Ltd

K-Number K210380

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HGX 2021-07-08

Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K-Number K203148

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IYO 2021-07-08

iSR'obot Mona Lisa 1.0

Applicant Biobot Surgical Pte., Ltd.

K-Number K203659

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CAF 2021-07-08

Nebulizer Kit

Applicant Excellentcare Medical (Huizhou) , Ltd.

K-Number K192971

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OLO 2021-07-08

StealthStation Spinous Process Clamps

Applicant Medtronic Navigation

K-Number K211442

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FCX 2021-07-08

END 200 Endoscopic Tubeset

Applicant Palliare , Ltd.

K-Number K202922

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