FilmArray GI Panel for use with FilmArray Torch

FDA registration

BioFire Diagnostics, LLC·1 product·🇺🇸 United States

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

DiREX

FDA registration

OSCOR INC.·1 product·🇺🇸 United States

Sterigenics U.S., LLC

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

INTERNATIONAL STERILIZATION LABORATORY, LLC

FDA registration

INTERNATIONAL STERILIZATION LABORATORY, LLC·1 product·🇺🇸 United States

Adelante Destino

FDA registration

OSCOR CARIBE LLC·1 product·🇩🇴 Dominican Republic

3M™ Unitek™

FDA UDI

3M UNITEK CORPORATION·00652221045386·Unitek(TM) Molar Band General Purpose Wide Regu...

50-7500B

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass

FDA registration

TDYLAN INTERNATIONAL FZE·1 product·🇦🇪 United Arab Emirates

Optimum Gp Ok

FDA registration

ACCU-LENS, INC.·1 product·🇺🇸 United States

Single Vision

FDA registration

Visionary Optics, LLC·1 product·🇺🇸 United States

SUCTION APPARATUS

FDA registration

SIGNA MEDICAL, INC.·1 product·🇺🇸 United States

IMPERIAL TRADING LIMITED

FDA registration

IMPERIAL TRADING LIMITED·1 product·🇧🇧 Barbados

BC-5390 Auto Hematology Analyzer

FDA registration

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.·1 product·🇨🇳 China

SUREFIRE INFUSION CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUADROSTAR 980

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheter, Intravascular, Diagnostic

FDA classification

FDA Class 2 ·Catheter, Intravascular, Diagnostic

Powered Laser Surgical Instrument

FDA classification

FDA Class 2 ·Powered Laser Surgical Instrument