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

IYN 2017-08-10

SmartUs EXT-1M/3M

Applicant Telemed

K-Number K163121

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DWF 2017-08-10

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

Applicant Surge Cardiovascular

K-Number K170488

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EBF 2017-08-10

Grandio blocs

Applicant Voco GmbH

K-Number K171200

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IPF 2017-08-09

StimSox(TM) System

Applicant Stimmed, LLC

K-Number K171071

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GEX 2017-08-09

M22 and ResurFx Systems

Applicant Lumenis, Ltd.

K-Number K170060

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GXI 2017-08-09

INTRACEPT Intraosseous Nerve Ablation System

Applicant Relievant Medsystems

K-Number K170827

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LPL 2017-08-09

DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K172066

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ITI 2017-08-09

Powered Wheelchair DYW30A(D09)

Applicant Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

K-Number K170787

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FTL 2017-08-09

Reperen Surgical Mesh

Applicant Iconlab, Inc.

K-Number K170134

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GEX 2017-08-09

Fraxis

Applicant Ilooda Co,., Ltd.

K-Number K172096

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JWH 2017-08-09

CKS Plus Knee System

Applicant Consensus Orthopedics, Inc.

K-Number K163167

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IYN 2017-08-09

WS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K171070

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