SENSITITRE STABILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

ADVANTA GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

PowerLook Tomo Detection V2 Software

FDA 510(k)

FDA Class 2 ·Radiology

PATHWAY II ELECTROMYOGRAPH

FDA 510(k)

FDA Class 2 ·Neurology

SOLUTION ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NEXFIN MODEL 2

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATRIUM MEDICAL CORPORATION ICAST COVERED STENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ICAD VERALOOK CTC CAD SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

ProFound AI Software V3.0

FDA 510(k)

FDA Class 2 ·Radiology

PERCUTANEOUS INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTENSION SET WITH CHECK VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

FLIXENE IFG VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aqueduct 100 Plus Cervical Dilation Balloon Catheter

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SELF CATH SET/SAFETY CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET

FDA 510(k)

FDA Class 2 ·General Hospital

TOMOPHASE OCTIS

FDA 510(k)

FDA Class 2 ·Radiology

DD URETERAL STENT, INTEGRAL STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BALLPEN SPINAL NEEDLE W/WO INTRODUCER

FDA 510(k)

FDA Class 2 ·Anesthesiology