Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard Stool DNA-Based Colorectal Cancer Screening Test

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Silk

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Voluma® XC

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

FDA Pre-Market Approval

FDA Class 3 ·Optilume™ BPH Catheter System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Skinvive by Juvéderm

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA®3 dermal filler

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Belotero Balance (+) Lidocaine

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris®

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM