Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Kit, Conception-Assist, Home Use

FDA classification

FDA Class 2 ·Kit, Conception-Assist, Home Use

Foot Examination Tool For Inflammatory Changes

FDA classification

FDA Class 1 ·Foot Examination Tool For Inflammatory Changes

Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

FDA classification

FDA Class 2 ·Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification

FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA classification

FDA Class 2 ·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

FDA classification

FDA Class 2 ·Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

FDA classification

FDA Class 2 ·Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

FDA classification

FDA Class 2 ·Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

FDA classification

FDA Class 2 ·System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

Container, Empty, For Collection & Processing Of Blood & Blood Components

FDA classification

FDA Class 2 ·Container, Empty, For Collection & Processing Of Blood & Blood Components

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

FDA classification

FDA Class 2 ·Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

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

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

FDA classification

FDA Class 2 ·Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

FDA classification

FDA Class 2 ·Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

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