MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800

FDA 510(k)

FDA Class 2 ·Hematology

MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

FDA 510(k)

FDA Class 2 ·Hematology

Flexset System

FDA 510(k)

FDA Class 2 ·Neurology

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

Clear Moves Aligner

FDA 510(k)

FDA Class 2 ·Dental

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

DEBP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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