Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·DUROLANE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GELS

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

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

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+HF FAMILY OF CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear