Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Senographe Pristina 3D

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·IOP (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GEL

CHIROFLEX II LENS MICROSERT(TM)

FDA 510(k)

FDA Class 3 ·Ophthalmic

OMS SILICONE OIL INJECTOR

FDA 510(k)

FDA Class 3 ·Ophthalmic

NIDEK DIGITAL KERATOMETER

FDA 510(k)

FDA Class 3 ·Ophthalmic

SOFTRANS INJECTOR

FDA 510(k)

FDA Class 3 ·Ophthalmic

AMER. MEDICAL OPTICS DIGITAL KERATO-

FDA 510(k)

FDA Class 3 ·Ophthalmic

CILCO ANTERIOR CHAMBER LENS

FDA 510(k)

FDA Class 3 ·Ophthalmic

POWERED EYE WASH

FDA 510(k)

FDA Class 3 ·Unknown

BIO-PEN CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown

NANOLAS ND:YAG OPHTHALMIC LASER

FDA 510(k)

FDA Class 3 ·Unknown

BIO-PEN SRK II CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown