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

MAX 2021-08-10

PSX Interbody System

Applicant Alphatec Spine, Inc.

K-Number K211873

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OAS 2021-08-10

EAGLE EDGE AXR90 and AXR120

Applicant Alliage S/A Industrias Medico Odontológica

K-Number K210820

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CBI 2021-08-10

sOLVe Tube

Applicant Hytek Medical, Inc.

K-Number K201026

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NKB 2021-08-10

KHEIRON Spinal Fixation System

Applicant S.M.A.I.O

K-Number K211414

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LZA 2021-08-10

Nitrile Patient Examination Glove

Applicant American Performance Polymers, LLC

K-Number K210730

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KIF 2021-08-10

Biodentine XP 500, Biodentine XP 200

Applicant Septodont

K-Number K211799

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LXB 2021-08-10

Ponto 5 Mini

Applicant Oticon Medical AB

K-Number K211640

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IYN 2021-08-09

X-CUBE 70

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K211299

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EOQ 2021-08-09

EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

Applicant Boston Scientific Corporation

K-Number K211030

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LZA 2021-08-09

Edma Synthetic Nitrile Examination Gloves

Applicant Edma Group, LLC

K-Number K211540

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IYN 2021-08-09

X-CUBE 90

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K211300

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LYZ 2021-08-08

Disposable Synthetic Vinyl Nitrile Examination Glove

Applicant Jiangsu Cureguard Glove Co., Ltd.

K-Number K211354

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