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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

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

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

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

FDA Pre-Market Approval

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

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

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE

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

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

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

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY PERENNIAFLEX

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION SYSTEM