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

GEX 2018-06-19

PICOPLUS Laser System

Applicant Lutronic Corporation

K-Number K173700

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MHX 2018-06-19

ViSi Mobile Monitoring System

Applicant Sotera Wireless, Inc.

K-Number K180472

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OHS 2018-06-19

Neutrogena Light Therapy Aging Mask+

Applicant Johnson & Johnson Consumer, Inc.

K-Number K180856

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KNW 2018-06-19

SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device

Applicant Transmed7, LLC

K-Number K173316

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GEI 2018-06-19

Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform

Applicant Covidien

K-Number K181389

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HGX 2018-06-18

GCE704 Breast Pump

Applicant Globalcare

K-Number K172842

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DQX 2018-06-18

Savion DLVR Guidewire, Savion FLX Guidewire

Applicant Boston Scientific, Inc.

K-Number K180726

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DZE 2018-06-18

IU Implant System

Applicant Warantec Co., Ltd.

K-Number K172345

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LJS 2018-06-18

Sherlock 3CG+ T ip Confirmation System

Applicant C.R. Bard, Inc.

K-Number K180560

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DXN 2018-06-18

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819

Applicant Ageless Health Industrial Co., Ltd.

K-Number K172895

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EBF 2018-06-18

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

Applicant Zirkonzahn Srl

K-Number K181484

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GYC 2018-06-18

SD LTM STIM Cortical Stimulator

Applicant Micromed S.P.A.

K-Number K180761

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