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

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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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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FXX 2021-08-19

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

Applicant Xianning Eco Medical Articles Co., Ltd.

K-Number K210698

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NHA 2021-08-19

s-Clean Pre-Milled Abutment

Applicant Dentis Co., Ltd.

K-Number K210362

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OOD 2021-08-19

SurgiLattice scaffold

Applicant Tepha, Inc.

K-Number K202425

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FXX 2021-08-19

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask

Applicant Xiantao S&J Protective Products Co., Ltd.

K-Number K211462

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