Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL NU-KNIT Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL™ Fibrillar Absorbable Hemostat, SURGICEL SNoW™ Absorbable Hemostat

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke® SCS System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL SNoW™ Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL® Absorbable Hemostats (SURGICEL® SNOW™)

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL® Absorbable Hemostats (SURGICEL® FIBRILLAR™, SURGICEL® SNOW)

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva Synthetic Cartilage Implant (Cartiva SCI)

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS patient and hospital electronics

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV-T

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·BELOS VR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540