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

DQX 2018-07-20

Bandit guidewire

Applicant Vascular Solutions, Inc.

K-Number K181647

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NPM 2018-07-20

The Graft Natural Bone Substitute

Applicant Purgo Biologics, Inc.

K-Number K173188

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CBK 2018-07-20

TV-100

Applicant Bio-Med Devices, Inc.

K-Number K173973

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KPR 2018-07-20

GC85A

Applicant Samsung Electronics Co., Ltd.

K-Number K181629

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OLZ 2018-07-20

NicoletOne

Applicant Natus Neurology Incorporated

K-Number K173366

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DQY 2018-07-20

WATCHMAN TruSeal Access System

Applicant Boston Scientific

K-Number K180864

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CDZ 2018-07-20

Free Testosterone AccuBind ELISA Test System

Applicant Monobind, Inc.

K-Number K181017

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MQB 2018-07-20

GR40CW

Applicant Samsung Electronics Co., Ltd.

K-Number K181631

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PGW 2018-07-20

TruDi NAV Suction Instruments

Applicant Acclarent, Inc.

K-Number K180948

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FRO 2018-07-20

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

Applicant Convatec Limited

K-Number K173675

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NAY 2018-07-19

da Vinci Xi Surgical System, da Vinci X Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K173585

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KNG 2018-07-19

Ultrasonic Doppler (Model YM-2T8)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K180419

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