Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH AND LOMB ELASTOFILCON A HYDROPHILIC CONTACT LENSES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR SOLUTIONS DUETT SEALING DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH AND LOMB LIDOFILCON A AND B HYDROPHILIC CONTACT LENSES

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Surpass Elite Flow Diverter System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION