1,677 results · 39ms · Sources: EU EUDAMED, US FDA

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification
FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

FDA classification
FDA Not Classified ·Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

FDA classification
FDA Class 2 ·Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

FDA classification
FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

FDA classification
FDA Class 2 ·Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

FDA classification
FDA Unclassified ·Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA classification
FDA Class 3 ·Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA classification
FDA Class 3 ·Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

FDA classification
FDA Not Classified ·System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification
FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

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

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

FDA classification
FDA Class 2 ·Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA classification
FDA Class 2 ·System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

FDA classification
FDA Class 2 ·Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

FDA classification
FDA Class 2 ·Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification
FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

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

Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

FDA classification
FDA Unclassified ·Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations