Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·NUVISC

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval

FDA Class 3 ·RESQCPR SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SCORPION & SCORPION M ABLATION CATHETERS

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANMENT CONTRACEPTION SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

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 (SNM) System

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER

Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME(TM)ENDOPROSTHESIS

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS)

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

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter