1,636 results · 20ms · Sources: EU EUDAMED, US FDA

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV 16/18

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Percepta Serena Solara Application; Percepta, Serena, Solara Quard CRT-P MRI SureScan.

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700/AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel®, Synergy® and Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris Sp

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump

Implanted Fecal Incontinence Device

FDA Pre-Market Approval
FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·OrganOx metra® System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Host, Platform, Common Application

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Sapien 3 Transcatheter Heart Valve

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR