Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric and Biofinity Toric Multifocal comfilcon A Soft (Hydrophilic) Contact Lenses

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT Laser

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony Toric II OptiBlue Extended Range of Vision Intraocular Lenses

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROTHESIS SYSTEM