9,662 results
·
49ms
·
Sources: EU EUDAMED, US FDA
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Prometra Programmable Infusion Pump System
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·CHARGER PTCA DILATION CATHETERS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·ARCTIC FRONT AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS
Neuromodulator For Obesity
FDA Pre-Market Approval
FDA Class 3
·MAESTRO RECHARGEABLE SYSTEM
Piston Syringe Lever
FDA classification
FDA Class 2
·Piston Syringe Lever
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Pneumoperitoneum Needle
FDA classification
FDA Class 2
·Pneumoperitoneum Needle
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·Animas Vibe System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVISC Opthalmic Viscoelastic Device
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPARED FUSION DEVICE
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·TLC-II PORTABLE VAD DRIVER
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME REVEL SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·CUTTING BALLOON
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·ENLITE GLUCOSE SENSOR
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System, Verify® Evaluation System