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

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FDA classification

FDA Class 2 ·System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification

FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

FDA classification

FDA Class 2 ·Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

FDA classification

FDA Class 2 ·Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

FDA classification

FDA Class 2 ·Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

FDA classification

FDA Class 2 ·Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

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

Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

FDA classification

FDA Class 1 ·Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification

FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

FDA classification

FDA Not Classified ·Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

FDA classification

FDA Class 2 ·Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

FDA classification

FDA Class 1 ·Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

FDA classification

FDA Class 2 ·Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate