487 results · 19ms · Sources: EU EUDAMED, US FDA

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