Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters Series Mechanical Heart Valve, 15mm HP

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTER HP VALVED GRAFT WITH GELWEAVE VALSALVA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·HP MRI Application Software, Visia AF Application Software

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters Series Mechanical Heart Valve, 15mm HP

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·PALACOS E-FLOW (OSTEOPAL) BONE CEMENT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit