Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX Injectable Gel

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Gore Cardioform ASD Occluder

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SpinalStim

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA,TELIGEN,ENERGEN,INCEPTA,VITALITY ICDS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE PROGLIDE/ AT AND PROSTAR XL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 EXCIMER LASER SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/ S VR/ XT DR/ XT VR ICD's ; Maximo II ICD; Pritectai I

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica® IM Hepatitis B e Antigen (HBeAg) Assay

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F)