Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·The Spanner Temporary Prostatic Stent

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ELEVESS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BARD ABLATION SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Lung System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE TRANSCAROTID STENT SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Trocar Knife

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMDOGAIN

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL)