Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA RC AND PC NEUROSTIMULATORS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+)

ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·MODEL SPF-60 SPINAL FUSION STIMULATOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 Mobile Continuous Glucose Monitoring System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·(WEB) Aneurysm Embolization System