10,000 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Primo MRITM SureScan TM & Mirro MRITM SureScan TM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·INSYNC FAMILIES OF CRT-ICD'S
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SELECTSECURE 3830
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·STAARVISC II & SHELLGEL SODIUM HYAURONATE
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus® UBT System
Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Orsiro Mission Sirolimus Eluting Coronary Stent System
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM and VIGILIANT (CRT-D Resynchroni
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Smartview Connect remote monitoring solution
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK CR2 Automated External Defibrillator
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME INSULIN INFUSINO PUMPS
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP