ISIS MER SYSTEM/ELEKTA MER SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MER BAG

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERILE DISPOSABLES FOR MER

FDA 510(k)

FDA Class 2 ·Neurology

MER MULTIPLANE RECTAL PROBE (MRP)

FDA 510(k)

FDA Class 2 ·Radiology

MER MULTIPLANE VAGINAL PROBE (MVP)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

APOFIX CERVICAL SPINE FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)

FDA Class 2 ·Pathology

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

SLM-1ER, SLM-2ER, SLM-3ER

FDA 510(k)

FDA Class 2 ·Ophthalmic

EER ERECTION ENHANCED RESPONDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRACHEAL TUBE LASER SHIELD KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRACHEAL TUBE LASER SHIELD KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

CERA COLOR

FDA 510(k)

FDA Class 2 ·Dental

CERA 8

FDA 510(k)

FDA Class 2 ·Dental