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

MMK 2021-08-06

Tiger Reusable Sharps Container

Applicant International Marketing Specialists, Inc.

K-Number K203305

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NAY 2021-08-06

da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)

Applicant Intuitive Surgical, Inc.

K-Number K211784

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MUE 2021-08-06

Senographe Pristina

Applicant GE Healthcare

K-Number K211725

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IYN 2021-08-06

Kosmos

Applicant EchoNous, Inc.

K-Number K212100

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NXC 2021-08-06

ClearCorrect System

Applicant Clearcorrect, LLC

K-Number K210320

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OLW 2021-08-05

NeuroSENSE Monitoring System, Model NS-901

Applicant Neurowave Systems, Inc.

K-Number K202621

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LZA 2021-08-05

Disposable Medical Nitrile Examination Gloves (Non-Sterile)

Applicant Jiangsu Cherish Medical Technology Co., Ltd.

K-Number K211075

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QPZ 2021-08-05

R2 Dermabrasion Tip (for Dermal Cooling System)

Applicant R2 Technologies, Inc.

K-Number K203006

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MSC 2021-08-05

Harmony Latex Dam, Harmony Non-Latex Dam

Applicant Pamco Distributing, Inc.

K-Number K203727

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PDJ 2021-08-05

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

Applicant Tosoh Bioscience, Inc.

K-Number K200904

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JEY 2021-08-05

Biomet Microfixation OmniMax MMF System

Applicant Biomet Microfixation

K-Number K202969

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LZA 2021-08-05

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)

Applicant Jiangsu Cureguard Glove Co., Ltd.

K-Number K211608

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