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

GEX 2016-07-28

Waterlase Express

Applicant Biolase, Inc.

K-Number K161669

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LLZ 2016-07-28

LVivo Software Application

Applicant Diacardio, Ltd.

K-Number K161382

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KPS 2016-07-28

MAMMI

Applicant General Equipment For Medical Imaging

K-Number K161631

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LIP 2016-07-28

Elecsys Syphilis

Applicant Roche Diagnostics

K-Number K160910

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OBO 2016-07-28

3D OCT-1 Maestro

Applicant Topcon Corporation

K-Number K161509

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EBF 2016-07-27

BEAUTIFIL II LS

Applicant Shofu Dental Corporation

K-Number K160596

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NUH 2016-07-27

HANAROCare ReJu

Applicant M.I.Tech Co., Ltd.

K-Number K160893

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OLO 2016-07-27

Precision Screw

Applicant Cryptych Pty, Ltd.

K-Number K160385

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PNQ 2016-07-27

Permaseal

Applicant Micro Interventional Devices,Inc.

K-Number DEN150029

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FRG 2016-07-27

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

Applicant Ahlstrom Nonwovens, LLC

K-Number K160755

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KIF 2016-07-27

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

Applicant Sybron Dental Specialties

K-Number K153067

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NDY 2016-07-27

Tina-quant Cystatin C Gen.2

Applicant Roche Diagnostics Operations (Rdo)

K-Number K161817

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