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

FMI 2018-03-21

DROPLET PEN NEEDLE

Applicant Htl-Strefa S.A

K-Number K171982

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GEH 2018-03-21

Freezpoint

Applicant Bovie Medical Corp.

K-Number K180211

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LLZ 2018-03-21

Emprint Ablation Visualization Application

Applicant Covidien, LLC

K-Number K180192

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LLZ 2018-03-21

WillCeph

Applicant Hdx Will Corp.

K-Number K172168

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OAP 2018-03-21

DermaScalp Laser Cap

Applicant Dermascalp, LLC

K-Number K173846

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MUE 2018-03-21

Mammomat Revelation

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K173408

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NTE 2018-03-21

WIRION

Applicant Gardia Medical , Ltd.

K-Number K180023

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FLL 2018-03-21

ATS Thermal Imaging Probe, ATS Patient Interface Unit

Applicant Securus Medical Group, Inc.

K-Number K180148

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KGE 2018-03-21

Captura® Disposable Hot Biopsy Forceps

Applicant Wilson-Cook Medical, Inc.

K-Number K171973

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LSL 2018-03-21

cobas CT/NG for use on cobas 6800/8800 systems

Applicant Roche Molecular Systems, Inc.

K-Number K173887

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OHT 2018-03-20

Home Use IPL Beauty Device

Applicant Shenzhen Mismon Technology Co., Ltd.

K-Number K180016

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PKL 2018-03-20

Single Use Hemoclip

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K172762

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