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

IVD-GE02

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

NEPHROS DSU-H, NEPHROS SSU-H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT

FDA 510(k)

FDA Class 2 ·Cardiovascular

.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LOW PROFILE STEERABLE BALLOON DILATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

.010 HI-TORQUE PLUS(TM) GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SELECTIVE INFUSION II CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular