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

LZA 2021-12-13

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color

Applicant Mexpo International, Inc.

K-Number K210388

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FYA 2021-12-13

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

Applicant Fugou County Shenxiang Manufacturing Co., Ltd.

K-Number K212869

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JAA 2021-12-13

Nyquist.IQ

Applicant Omega Medical Imaging, LLC

K-Number K212890

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NUH 2021-12-13

Heat StimPlus

Applicant Famidoc Technology Co., Ltd.

K-Number K212918

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KPR 2021-12-13

MULTIX Impact, MULTIX Impact C

Applicant Siemens Medical Solutions USA, Inc.

K-Number K213700

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OBR 2021-12-13

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

Applicant Splintek, Inc.

K-Number K212706

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LZA 2021-12-11

Nitrile Gloves (Model: NE01)

Applicant Byd Auto Industry Company Limited

K-Number K212840

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FXX 2021-12-11

Medical Surgical Mask

Applicant Nanchang Kanghua Health Materials Co., Ltd.

K-Number K212867

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LZA 2021-12-11

Iconic Nitrile Glove

Applicant Iconic Medicare Sdn Bhd

K-Number K212182

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LZA 2021-12-11

Siam NTD+ Nitrile Powder-Free Examination gloves

Applicant Siam Ntd Corporation Co., Ltd.

K-Number K212085

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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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