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 2021-08-11

Surgical mask

Applicant Shandong Shengquan New Materials Co., Ltd.

K-Number K211552

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FXX 2021-08-11

Medical Face Mask

Applicant Shenzhen Lyttop Healthcare Limited

K-Number K211353

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QLG 2021-08-11

FreeStyle Libre 2 Flash Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K211102

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LZA 2021-08-11

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K202536

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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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