743 results · 23ms · Sources: EU EUDAMED, US FDA

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

FDA classification
FDA Class 2 ·Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Variola Virus Nucleic Acid-Based Detection Assay

FDA classification
FDA Class 2 ·Variola Virus Nucleic Acid-Based Detection Assay

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification
FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

FDA classification
FDA Class 2 ·Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Isocapnic Ventilation Device

FDA classification
FDA Class 2 ·Isocapnic Ventilation Device

Antimicrobial Blood Pressure Cuff

FDA classification
FDA Class 2 ·Antimicrobial Blood Pressure Cuff

Low Dead Space Needle, Single Lumen, Hypodermic

FDA classification
FDA Class 2 ·Low Dead Space Needle, Single Lumen, Hypodermic

Dislodger, Stone, Flexible, Ureteral, Reprocessed

FDA classification
FDA Class 2 ·Dislodger, Stone, Flexible, Ureteral, Reprocessed

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification
FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Enzyme Immunoassay, Cortisol, Salivary

FDA classification
FDA Class 2 ·Enzyme Immunoassay, Cortisol, Salivary

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA classification
FDA Class 2 ·Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

FDA classification
FDA Class 2 ·Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Prostate Immobilizer Rectal Balloon

FDA classification
FDA Class 2 ·Prostate Immobilizer Rectal Balloon

Needle, Phacoemulsification, Reprocessed

FDA classification
FDA Class 2 ·Needle, Phacoemulsification, Reprocessed

Table Mounted Miniaturized Electromechanical Surgical System

FDA classification
FDA Class 2 ·Table Mounted Miniaturized Electromechanical Surgical System

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification
FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

FDA classification
FDA Class 2 ·Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Integrated Continuous Glucose Monitoring System, Factory Calibrated

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification
FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Orthosis, Cranial, Laser Scan

FDA classification
FDA Class 2 ·Orthosis, Cranial, Laser Scan