Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

Medtronic Extended infusion set

FDA 510(k)

FDA Class 2 ·General Hospital

neria guard Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

MiniMed Mio Advance infusion set

FDA 510(k)

FDA Class 2 ·General Hospital

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

FDA 510(k)

FDA Class 2 ·General Hospital

SAFE-1(TM) SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LONGBOW SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AILERON INTERSPINOUS FIXATION 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

TECNADYNE 20/20 FOG INHIBITOR KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIGI-FIX HIP STEM SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ODI 7.0MM CANNULATED SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ODI ULTIMATE COMPRESSION HIP SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators