SERAGARD VASCULAR ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

EVOL® -SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOL® ha-C Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS EDGE(TM) CORONARY DILITATION CATHETER

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nephros S100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EndoPur Filter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HydraGuard 10 UltraFilter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEPHROS DSU-H, NEPHROS SSU-H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEBP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLINKY(TM),EDGE(TM),QUICK(TM),PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

FDA 510(k)

FDA Class 2 ·Radiology