Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT/DUOVISC Ophthalmic Viscoelastic System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOL LENS MODEL GR1A

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ANTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LASER WELDING REVERSE HAPTIC ASPECT RATIO

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV ABSORBING POST.CHAM.IOL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE