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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim SCS IPG

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity DBS IPG

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filter

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG IPG

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE VASCULAR CLOSURE SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR

TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)

FDA Class 3 ·Cardiovascular

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·C/T SERIES/SELECTION/DIAMOND II/JADE II/RUBY II/TOPAZ II/VITA/VITA II/DEMA FAMILY OF IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA FAMILY (INCLUDES CLARITY DDDR, CLARITY SSIR, DIAMOND III, RUBY III, TOPAZ III, JADE III, VITA DDDR AND VITA II)

ACETABULAR DOME HOLE PLUGS

FDA 510(k)

FDA Class 3 ·Orthopedic

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES