PATIENTGALLERY IMAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

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

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

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·AFP CONTROL PACK

CONSULTIVA REPORT STATION, MODEL RS-1

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

SI-Restore Sacroiliac Joint Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic