Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS