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

LLZ 2018-11-30

XVWeb 3D

Applicant Apteryx, Inc.

K-Number K182815

View Details →

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

View Details →

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

View Details →

PCS 2018-11-30

FerriSmart Analysis System

Applicant Resonance Health Analysis Services Pty, Ltd.

K-Number K182218

View Details →

QEC 2018-11-30

Single Use Hot Biopsy Forceps FD-231

Applicant Olympus Medical Systems Corp.

K-Number K173495

View Details →

DXH 2018-11-30

Prizma

Applicant G-Medical Innovations , Ltd.

K-Number K173589

View Details →

ONB 2018-11-30

BD PhaSeal Optima Closed System Transfer Device

Applicant Becton, Dickinson and Company

K-Number K181221

View Details →

EOB 2018-11-30

Ambu aScope RLS Slim

Applicant Ambu A/S

K-Number K181286

View Details →

LPL 2018-11-30

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

Applicant Bausch & Lomb, Incorporated

K-Number K182249

View Details →

PCH 2018-11-30

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

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K183023

View Details →

OMP 2018-11-30

UNO Negative Pressure Wound Therapy System

Applicant Genadyne Biotechnologies, Inc.

K-Number K180840

View Details →

QDZ 2018-11-30

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

Applicant Meridian Bioscience, Inc.

K-Number DEN180040

View Details →

Page 1939 of 2685

↑