Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, Colla Tape, CollaPlug, Absorable Collagen Wound Dressing for Dental Surgery

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·TRIDYNE Vascular Sealant

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Mometasone Furoate Container Closure System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREST IMPLANTS

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT AND HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM