10,000 results
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46ms
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Sources: EU EUDAMED, US FDA
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Simplify Cervical Artificial Disc
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Symfony Toric IOL
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·TEGRESS URETHRAL IMPLANT
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ATLAS II HF, ATLAS+ HF, ATLAS II+ HF, EPIC HF, EPIC II HF, EPIC+ HF, EPIC II+ HF, PROMOTE
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC PVAD SYSTEM AND TLC-II PORTABLE VAD DRIVER
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSUREFIX MRI SURESCAN LEAD, 5086MRI
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS patient and hospital electronics
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER Duct Occluder, Occluder II; AMPLATZER Piccolo Occluder
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·Visian ICL (Implantable Collamer Lens)
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MemoryGel Enhance Silicone Breast Implants
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TACTICATH QUARTZ ABLATION CATHETER
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP 2000 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
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD PREPMATE SLIDE PROCESSOR, BD PREPMATE AUTOMATED ACCESSORY
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM