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

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

GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEPHROS DSU-H, NEPHROS SSU-H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XBeam (v2)

FDA 510(k)

FDA Class 2 ·Radiology

Photoelectric Therapy System

FDA 510(k)

FDA Class 2 ·Radiology

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

FDA 510(k)

FDA Class 2 ·Radiology

Daye Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology