Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4 Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

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

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® Redensity™, RHA®2, RHA®3, RHA®4 Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4 Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity, RHA®2, RHA®3 and RHA® Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 3 Mepi

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4 Dermal Fillers

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SPINAL CORD STIMULATION SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·COHERENT OPAL PHOTOACTIVATOR

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra® System

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alere NMP22 BladderChek Test

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM