SPIRAL FLOW PERIPHERAL VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-HA-IGMK PLUS KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-HA-IGMK

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-AB-HAVK

DTI-1 SLA IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-AB-HAVK PLUS

Carex Hybrid Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

GEM-STIM COMBO STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP

FDA 510(k)

FDA Class 2 ·Neurology

GEM-TWIN TENS/ MODELS GM3XY/Z

FDA 510(k)

FDA Class 2 ·Neurology

GEMORE OTC TENS

FDA 510(k)

FDA Class 2 ·Neurology

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

ShiNeo Silicone Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ORANGE COLORED CONDOMS ORANGE SCENT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

FDA 510(k)

FDA Class 2 ·Clinical Chemistry