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

FRO 2022-12-21

Extra Silver Gelling Fiber Dressing

Applicant Winner Medical Co., Ltd.

K-Number K221720

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MGZ 2022-12-21

LimFlow Vector

Applicant LimFlow, Inc.

K-Number K221902

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NHJ 2022-12-21

BiWaze Clear System

Applicant Abmrc, LLC

K-Number K213564

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QUH 2022-12-21

Eargo 5 , Eargo 6

Applicant Eargo, Inc.

K-Number K221698

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KRD 2022-12-21

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

Applicant MicroVention, Inc.

K-Number K223050

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MNR 2022-12-21

BresoDX1

Applicant Bresotec, Inc.

K-Number K220012

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MHX 2022-12-21

Mural Clinical Viewer

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K222586

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IYN 2022-12-21

VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP

Applicant Vinno Technology (Suzhou) Co.,Ltd

K-Number K221911

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JTN 2022-12-21

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

Applicant Becton, Dickinson and Company

K-Number K221826

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OHS 2022-12-21

reVive Light Therapy® Wrinkle and Acne LED Device

Applicant Led Technologies, Inc.

K-Number K223482

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FBK 2022-12-21

CORE-INJECTOR

Applicant Incore Co., Ltd.

K-Number K221054

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LFH 2022-12-21

DRI TM Tricyclics Serum Tox Assay

Applicant Microgenics Corporation

K-Number K213875

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