Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Device Command Library (DCL), CareLine Express

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne and Restylane Defyne Injectable Gels

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Radiesse(+) Lidocaine

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed Hybrid Closed Loop (HCL) 670G

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Injectable Gels

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL)

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENSES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Kysse Injectable Gel

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Instrument Command Library (ICL), Device Command Library (DCL)

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE Injectable Gels

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK INSTRUMENT COMMAND LIBRARY, MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR.

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian Implantable Collamer Lens for Myopia

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer UV Absorbing Posterior Chamber Intraocular Lens

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR