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

LZA 2021-08-20

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue

Applicant Careplus (M) Sdn Bhd

K-Number K201857

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LZA 2021-08-20

Nitrile Exam Gloves, Powder Free, Blue

Applicant Hengchang (Dongying) Medical Technology Co., Ltd.

K-Number K211699

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IYN 2021-08-20

Exo Iris

Applicant Exo Imaging, Inc.

K-Number K211527

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LLZ 2021-08-20

Ez3D-i/E3

Applicant Ewoosoft Co., Ltd.

K-Number K211791

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FXX 2021-08-19

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3

Applicant Homtex, Inc.

K-Number K211066

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MYC 2021-08-19

EIDON FA, EIDON, EIDON AF, EIDON UWFL

Applicant Centervue S.P.A.

K-Number K211328

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FDS 2021-08-19

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

Applicant Fujifilm Corporation

K-Number K212296

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QGQ 2021-08-19

OsteoProbe

Applicant Active Life Scientific, Inc.

K-Number DEN210013

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KPE 2021-08-19

Empty EVA Bag

Applicant Haemotronic S.P.A.

K-Number K210749

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KDN 2021-08-19

Servator P SALF Solution with THAM

Applicant S.A.L.F. Spa

K-Number K202652

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PIF 2021-08-19

Enteral Extension Sets

Applicant GBUK Group, Ltd.

K-Number K203633

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LYY 2021-08-19

Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

Applicant Shen Wei USA, Inc.

K-Number K211620

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