814 results · 20ms · Sources: EU EUDAMED, US FDA

Plasmodium Spp. Detection Reagents

FDA classification
FDA Class 2 ·Plasmodium Spp. Detection Reagents

Immunoassay, Anti-Seizure Drug

FDA classification
FDA Class 2 ·Immunoassay, Anti-Seizure Drug

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK

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

FDA Pre-Market Approval
FDA Class 2 ·COBAS TAQMAN HCV TEST VERSION 2.0

Hemoglobin A1c Test System

FDA classification
FDA Class 2 ·Hemoglobin A1c Test System

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

FDA classification
FDA Class 2 ·Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Endoscopic Tissue Approximation Device

FDA classification
FDA Class 2 ·Endoscopic Tissue Approximation Device

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

FDA classification
FDA Class 2 ·Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Prosthesis, Eyelid Spacer/Graft, Biologic

FDA classification
FDA Class 2 ·Prosthesis, Eyelid Spacer/Graft, Biologic

Percutaneous Nerve Stimulator For Opioid Withdrawal

FDA classification
FDA Class 2 ·Percutaneous Nerve Stimulator For Opioid Withdrawal

Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

FDA classification
FDA Class 2 ·Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Abutment, Implant, Dental, Endosseous

FDA classification
FDA Class 2 ·Abutment, Implant, Dental, Endosseous

Endoscopic Access Overtube, Gastroenterology-Urology

FDA classification
FDA Class 2 ·Endoscopic Access Overtube, Gastroenterology-Urology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

FDA classification
FDA Class 2 ·Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse

FDA classification
FDA Class 2 ·Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse

Prosthesis, Eyelid Spacer/Graft, Polymer

FDA classification
FDA Class 2 ·Prosthesis, Eyelid Spacer/Graft, Polymer

Coronary Vascular Physiologic Simulation Software

FDA classification
FDA Class 2 ·Coronary Vascular Physiologic Simulation Software

Thymidine Kinase Activity

FDA classification
FDA Class 2 ·Thymidine Kinase Activity

Neurologic Disease Risk Assessment Molecular Test

FDA classification
FDA Class 2 ·Neurologic Disease Risk Assessment Molecular Test