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

LYZ 2021-12-11

Disposable Vinyl/Nitrile Blend Medical Examination Gloves

Applicant Bytech(Dongtai) Co., Ltd.

K-Number K212899

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NKG 2021-12-10

Vy Spine VySpan PCT System

Applicant Vy Spine, LLC

K-Number K213394

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GEX 2021-12-10

UltraClear Fractional Laser System

Applicant Fa International, LP

K-Number K210847

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FYA 2021-12-10

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

Applicant Unicoglobal, Inc.

K-Number K203539

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LZA 2021-12-10

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves

Applicant Medi Legion Sdn.Bhd

K-Number K212349

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DYB 2021-12-10

Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)

Applicant Argon Medical Devices

K-Number K213638

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LZA 2021-12-10

ComfortPro Blue Nitrile Examination Gloves Powder Free

Applicant Thai Rubber Industry Company Limited

K-Number K212850

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OBP 2021-12-10

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

Applicant Neuronetics, Inc.

K-Number K213543

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QJP 2021-12-10

Branchor Balloon Guide Catheter

Applicant Asahi Intecc Co., Ltd.

K-Number K203723

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NKB 2021-12-10

Invictus Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K213460

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NHA 2021-12-10

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K212577

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NAY 2021-12-10

8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K211997

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