Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE Injectable Implant

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1%OVD (fonnerly BD 1%OVD and Biolon)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 780G System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACH HEADER, END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)