Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL Vascular Closure Devices

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEMS & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP Ventricular Support System

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

FDA Pre-Market Approval

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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·AMS ACTICON NEOSPHINCTER

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMBICOR INFLATABLE PENILE PROSTHESIS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Catheter and HeartLight Console

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON - TB GOLD-IN-TUBE