Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval

FDA Class 3 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALOGIC BONE GROWTH STIMULATOR

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICAL SNOW ABSORBABLE HEMOSTAT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System Next Generation Active Anchor, TrueLock

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES