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

FDS 2018-03-01

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603

Applicant Fujifilm Corporation

K-Number K172916

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HTN 2018-03-01

PUMA System

Applicant Panther Orthopedics, Inc.

K-Number K171703

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FXX 2018-03-01

Technoweb Surgical Mask

Applicant Yts Global, Inc.

K-Number K172500

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HAW 2018-03-01

Microscope Navigation Software

Applicant Brainlab AG

K-Number K172820

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OWB 2018-02-28

TrackX

Applicant Track X Technology, LLC

K-Number K173736

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OAP 2018-02-28

Diode Laser Cap

Applicant Cosmo Far East Technology Limited

K-Number K173678

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PLA 2018-02-28

EnsoETM

Applicant Advanced Cooling Therapy, Inc. D/B/A Attune Medical

K-Number K180244

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DSA 2018-02-28

ECG Cable/Leadwires

Applicant Shenzhen Coreray Technology, Ltd.

K-Number K172797

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PTH 2018-02-28

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K180255

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OBO 2018-02-28

P200TE

Applicant Optos Plc.

K-Number K173707

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GXH 2018-02-28

iovera system

Applicant Myoscience, Inc.

K-Number K173763

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JWY 2018-02-28

Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL

Applicant Liofilchem s.r.l.

K-Number K173817

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