Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PS50C-OUV

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OUS Vitatron Application Software

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OUS Vitatron Application Software

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OUS HeartTone MRI Application Software

ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J

FDA 510(k)

FDA Class 3 ·Cardiovascular

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA™ Implant System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFPORT/SOFLEX INTRAOCULAR LENSES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 3

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR)

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular,

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD System