Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MARGINPROBE SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG LEADS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MATRIX VASCULAR CLOSURE SYSTEM (VSG)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MATRIX VASCULAR CLOSURE SYSTEM (VSG)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S /GS /G

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE™ G/SG with 4-SITE™ Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS+ FAMILY OF PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS & DROMOS SL PULSE GENERATORS