Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·PROCOL VASCULAR BIOPROSTHESIS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION PUMP

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G3 Pro AED

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System (Bowel)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR AND GENFIND KIT

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PROSORBA COLUMN

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·MONOVISC

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist, Impella 5.5 with SmartAssist

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)