9 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Adapta, Versa, Sensia IPG, Relia IPG
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Optoacoustic Imaging System
FDA Pre-Market Approval
FDA Class 3
·Imagio® Breast Imaging system
Optoacoustic Imaging System
FDA Pre-Market Approval
FDA Class 3
·Imagio Breast Imaging System