Analyzer, Medical Image

FDA Pre-Market Approval

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

Analyzer, Medical Image

FDA Pre-Market Approval

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

SLEEPMASTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYSTEM, TOMOGRAPHIC, NUCLEAR

FDA 510(k)

FDA Class 2 ·Radiology

HF MEGA EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PLAYTONE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HALOLITE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

FREEWAY LITE NEBULIZER COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIDESTREAM DISPOSABLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTSTREAM DRUG NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

KEYNOTE

FDA 510(k)

FDA Class 2 ·Physical Medicine

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIDESTREAM DRUG NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDORINGS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORT-NEB

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

LMT-3000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Neurosteer EEG Recorder

FDA 510(k)

FDA Class 2 ·Neurology

LEXUS CERVICAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic