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

FLL 2018-11-30

welloStationX

Applicant Wello, Inc.

K-Number K180298

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BZC 2018-11-30

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

Applicant Vyaire Medical, Inc.

K-Number K181524

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LLZ 2018-11-30

XVWeb 3D

Applicant Apteryx, Inc.

K-Number K182815

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NBW 2018-11-30

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System

Applicant Tyson Bioresearch, Inc.

K-Number K182046

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LZA 2018-11-30

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K182600

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PCS 2018-11-30

FerriSmart Analysis System

Applicant Resonance Health Analysis Services Pty, Ltd.

K-Number K182218

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QEC 2018-11-30

Single Use Hot Biopsy Forceps FD-231

Applicant Olympus Medical Systems Corp.

K-Number K173495

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DXH 2018-11-30

Prizma

Applicant G-Medical Innovations , Ltd.

K-Number K173589

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ONB 2018-11-30

BD PhaSeal Optima Closed System Transfer Device

Applicant Becton, Dickinson and Company

K-Number K181221

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EOB 2018-11-30

Ambu aScope RLS Slim

Applicant Ambu A/S

K-Number K181286

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LPL 2018-11-30

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

Applicant Bausch & Lomb, Incorporated

K-Number K182249

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PCH 2018-11-30

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K183023

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