3,082 results · 18ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Genus Deep Brain Stimulation System

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval
FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACS: CENTAUR AFP IMMUNOASSAY

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SOF SENSOR

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·DRIVER MX2 CORONARY STENT SYSTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·Raindrop Near Vision Inlay

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOPAK II BONE GROWTH STIMULATOR

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION TREATMENTS

Glenoid Fossa Prosthesis

FDA Pre-Market Approval
FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM