Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW/OTW/CS LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LEAD ASSEMBLY

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT, MODEL 150

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·DUROLANE

MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ECOMED SCALP VEIN SET

FDA 510(k)

FDA Class 2 ·General Hospital

VACUETTE MULTI-SAMPLE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

VACUETTE HOLDEX

FDA 510(k)

FDA Class 2 ·General Hospital

GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Revitalair 430F

FDA 510(k)

FDA Class 2 ·Anesthesiology

GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VACUETTE (MULTI-USE HOLDER)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEFLEX

FDA 510(k)

FDA Class 2 ·Dental

GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEFLEX ACRILATO

FDA 510(k)

FDA Class 2 ·Dental

ODONT HEX SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NEUROTUBE

FDA 510(k)

FDA Class 2 ·Neurology