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

PLF 2019-12-23

Trigon Ti Stand-Alone Wedge Fixation System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K192645

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LZA 2019-12-23

Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K192104

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DXO 2019-12-23

Comet II Pressure Guidewire

Applicant Boston Scientific Corporation

K-Number K193279

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IPF 2019-12-23

RelieforMe TENS/EMS Device Model UPK-GE01

Applicant Umeheal , Ltd.

K-Number K192733

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LZA 2019-12-23

Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs

Applicant Ever Growth (Vietnam) Co. , Ltd.

K-Number K190736

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DXN 2019-12-23

Arm Blood Pressure Monitor

Applicant Truly Instrument Limited

K-Number K192023

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KCT 2019-12-23

EZ-TRAX Containment Device

Applicant K1 Medical, LLC

K-Number K192487

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QIS 2019-12-23

Mucosal Integrity Conductivity (MI) Test System

Applicant Diversatek Healthcare, Inc.

K-Number DEN180067

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OCC 2019-12-23

BioCode Respiratory Pathogen Panel (RPP)

Applicant Applied BioCode, Inc.

K-Number K192485

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JOJ 2019-12-23

3M Attest Steam Chemical Integrator

Applicant 3M Company

K-Number K193254

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PHX 2019-12-23

Arthrex Univers Revers Modular Glenoid System

Applicant Arthrex, Inc.

K-Number K191960

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HRS 2019-12-23

Mini and Micro Fragments Reconstruction System GMReis

Applicant Gm Dos Reis Industria E Comerico Ltda.

K-Number K182718

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