Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEADS SERVICE & WRENCH KIT

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

ECOMED SCALP VEIN SET

FDA 510(k)

FDA Class 2 ·General Hospital

VACUETTE MULTI-SAMPLE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

THORACIC SUPPORT SYSTEM

FDA 510(k)

FDA Class 1 ·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

BowTie™ SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTAL RADIO-ULNAR JOINT IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

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