991 results · 31ms · Sources: EU EUDAMED, US FDA

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard®

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·SMART CONTROL NITINOL STENT SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·SOUNDTEC DIRECT IPCA SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SCS Implantable Neurostimulators

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Ev

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,Cobalt MR

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval
FDA Class 3 ·OPRA™ Implant System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLUORON OCULAR ENDOTAMPONADE

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·R3 Delta Ceramic Hip System

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·THINPREP 3000 PROCESSOR

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator