487 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Trifecta and Trifecta GT surgical Heart Valve
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·Amplatzer Septal Occluder and Amplatzer Cribriform Occluder
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·Amplatzer Patent FOramen Ovale Occluder
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Biocor and Epic Valves
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR, O2 OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM,AIR OPTIX AQUA
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Pleural Air Leak Sealant
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·AIR OPTIX FOR ASTIGMATISM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System (LVAS)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate II Left Ventricular Assist System (LVAS)
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
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT
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
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·SWEDISH ADJUSTABLE GASTRIC BAND
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND-C