O2 NASAL CANNULA WITH CO2 MONITORING

FDA 510(k)

FDA Class 2 ·Anesthesiology

DUALGUARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLEXICARE BREATHING FILTERS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Flexicare Heated Wire Breathing Systems

FDA 510(k)

FDA Class 2 ·Anesthesiology

INSPIRAID VA-1 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

POWERPLAY MUSCLE MASSAGER

FDA 510(k)

FDA Class 2 ·Physical Medicine

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

FDA 510(k)

FDA Class 2 ·Microbiology

MD-2300S Ultrasonic A/B Scanner for Ophthalmology

FDA 510(k)

FDA Class 2 ·Radiology

MD-6000P Bladder Scanner

FDA 510(k)

FDA Class 2 ·Radiology

MD-320W Ultrasound Biomicroscope

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Self-Fitting hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sontro® OTC Hearing Aids (AI)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Eargo 5 , Eargo 6

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Intrisound™ Tuned Lumen® 155 Hearing Aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Concha Sol Hearing Aids (CL-1001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat