535 results · 19ms · Sources: EU EUDAMED, US FDA

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·ADEPT Adhesion Reduction Solution

AMS SPHINCTER 800 URINARY PROSTHESIS

FDA 510(k)
FDA Class 3 ·Unknown

THE ARTIFICIAL URINARY SPHINCTER

FDA 510(k)
FDA Class 3 ·Unknown

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN 2000+ BONE HEALING SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Implantable System for Remodulin

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Pump, Infusion, Implanted, Programmable

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

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS Bowel: InterStim Therapy System and Verify Evaluation System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·DERMAGRAFT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS Urinary: InterStim Therapy System and Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Renal

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POSTERIOR CHAMBER IOL

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TAG THORACIC ENDOPROSTHESIS

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD RENAL PREMOUNTED STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·REBEL MONORAIL AND OVER THE WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Plasmaflo OP-05W(A)