Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·STARFLEX SEPTAL OCCLUSION SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QUICK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER (CM LLT, CM T LINE AND CM II)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·VIBRANT SOUNDBRIDGE SYSTEM

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 60 (OCUFILCON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System