Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT

Antibody To Htlv-1, Elisa

FDA classification

FDA Class 3 ·Antibody To Htlv-1, Elisa

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification

FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Cranial Electrotherapy Stimulator To Treat Depression

FDA classification

FDA Class 3 ·Cranial Electrotherapy Stimulator To Treat Depression

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification

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

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS

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