SAFE-1(TM) SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

LONGBOW SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AILERON INTERSPINOUS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NAUTILUS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PLATEAU SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

RANSFORD CERVICAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SX-One MicroKnife

FDA 510(k)

FDA Class 1 ·Orthopedic

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Family of Implantable Pulse Generators

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM215 Growth Factor Enhanced Matrix

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ADAPTER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Extensions

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HC Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic