Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL ES (ES DEVICE)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·lnterStim Therapy System, Verify Evaluation System (SNS Urinary)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·lnterStim Therapy System, Verify Evaluation System (SNS Bowel)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION TREATMENTS

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE