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, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ATTUNE Revision RP Tibial Base

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TRULIGN TORIC WEB-BASED TORIC CALCULATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Device Manager Base, 24970A

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TRULIGN TORIC WEB BASED TORIC CALCULATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC PACEMAKER PROGRAMMER & BASE STATION

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC PACEMAKER PROGRAMMER & BASE STATION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY