GEM-TONE BODY TRAINING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

iSR'obot Biopsy Kit

FDA 510(k)

FDA Class 2 ·Radiology

iSR'obot MRI-US Fusion

FDA 510(k)

FDA Class 2 ·Radiology

GEMORE TENS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BR-FHUS Navigation 1.0

FDA 510(k)

FDA Class 2 ·Radiology

GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

GIM-STIM OTC TENS/EMS System

FDA 510(k)

FDA Class 2 ·Neurology

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

FDA 510(k)

FDA Class 2 ·Neurology

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

BR-ABVS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

SIRIUS Endoscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BR-FHUS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·MICROVEL(R) WITH HEMASHIELD

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·MICROVEL(R) WITH HEMASHIELD