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

HET 2017-11-28

LAP-iX Suction Irrigation

Applicant Sejong Medical Co., Ltd.

K-Number K173111

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EIH 2017-11-28

DIAZIR

Applicant Zxtgy (Beijing) Technology Co., Ltd.

K-Number K161652

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MOS 2017-11-28

DuoFLEX Coil Suite

Applicant Mr Instruments, Inc.

K-Number K173290

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CAF 2017-11-28

Portable Nebulizer

Applicant Microbase Technology Corporation

K-Number K170916

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PCC 2017-11-28

Cefaly Dual

Applicant Cefaly Technology

K-Number K173006

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HRS 2017-11-28

Ankle Fusion Plating System

Applicant In2bones Sas

K-Number K173121

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LZC 2017-11-28

Orange Non Sterile Powder Free Nitrile Examination Gloves

Applicant Central Medicare Sdn Bhd

K-Number K172642

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KLE 2017-11-28

TOKUYAMA UNIVERSAL BOND

Applicant Tokuyama Dental Corporation

K-Number K171226

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LRK 2017-11-28

Meridian PM

Applicant The Center For Craniofacial & Dental Sleep Medicine

K-Number K170053

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HQF 2017-11-27

PSLT for PASCAL Streamline

Applicant Topcon Medical Laser Systems, Inc.

K-Number K171488

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JOW 2017-11-27

Devon 51

Applicant Devon Medical Products (Jiangsu), Ltd.

K-Number K172030

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MRC 2017-11-27

Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions

Applicant Bausch & Lomb, Incorporated

K-Number K173089

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