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

EBW 2018-06-19

Surgic Pro, Surgic Pro+

Applicant Nakanishi, Inc.

K-Number K173905

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NLH 2018-06-19

Reprocessed DecaNav Diagnostic Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K180710

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LLZ 2018-06-19

sterEOS Workstation

Applicant Eos Imaging

K-Number K172346

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OLP 2018-06-19

Neutrogena Light Therapy Acne Mask+

Applicant Johnson & Johnson Consumer, Inc.

K-Number K180847

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NBW 2018-06-19

Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

Applicant Bionime Corporation

K-Number K173139

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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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