FRACTORA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEDIATRIC INGESTASCAN

FDA 510(k)

FDA Class 2 ·Ophthalmic

RAPID Web

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Geneo X Elite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01

FDA 510(k)

FDA Class 2 ·Cardiovascular

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPINEMED

FDA 510(k)

FDA Class 2 ·Physical Medicine

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReDS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILATATION CATHETERS