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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification

FDA Class 3 ·Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

SYRIGENE PRE-FILLED SYRINGE

FDA 510(k)

FDA Class 3 ·Orthopedic

NORFOLK MEDICAL PERITONEAL-ACCESS PORT

FDA 510(k)

FDA Class 3 ·Unknown

Gases Used Within Eye To Place Pressure On Detached Retina

FDA classification

FDA Class 3 ·Gases Used Within Eye To Place Pressure On Detached Retina

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA classification

FDA Class 3 ·Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification

FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

FDA classification

FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA classification

FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA classification

FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA classification

FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification

FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Kit, Chemical Snake-Bite

FDA classification

FDA Class 3 ·Kit, Chemical Snake-Bite

Catheter, Percutaneous, Long Term, Intraspinal

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Long Term, Intraspinal

Pump, Drug Administration, Closed Loop

FDA classification

FDA Class 3 ·Pump, Drug Administration, Closed Loop

Controller, Closed-Loop, Blood-Pressure

FDA classification

FDA Class 3 ·Controller, Closed-Loop, Blood-Pressure

Pump, Infusion, Implanted, Programmable

FDA classification

FDA Class 3 ·Pump, Infusion, Implanted, Programmable

Device, Peritoneal Access, Subcutaneous, Implanted

FDA classification

FDA Class 3 ·Device, Peritoneal Access, Subcutaneous, Implanted