Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT PY-60AD

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Surpass Elite Flow Diverter System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·AccelStim

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT MODEL PC-60AD PACKAGING IMPROVEMENT

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS