1,888 results · 45ms · Sources: EU EUDAMED, US FDA

Process Control

FDA classification
FDA Not Classified ·Process Control

Susceptibility Test Plate, Antifungal

FDA classification
FDA Class 2 ·Susceptibility Test Plate, Antifungal

Ankle Fusion Cage

FDA classification
FDA Class 2 ·Ankle Fusion Cage

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification
FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification
FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification
FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

25-Oh-Vitamin D Mass Spectrometry Test System

FDA classification
FDA Class 2 ·25-Oh-Vitamin D Mass Spectrometry Test System

Hydrophilic Re-Coating Solution

FDA classification
FDA Class 2 ·Hydrophilic Re-Coating Solution

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

FDA classification
FDA Class 2 ·Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Interoperable Automated Glycemic Controller

FDA classification
FDA Class 2 ·Interoperable Automated Glycemic Controller

Complete Gene Expression Profiling Accessory Reagents

FDA classification
FDA Class 2 ·Complete Gene Expression Profiling Accessory Reagents

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Alternate Controller Enabled Insulin Infusion Pump

FDA classification
FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

FDA classification
FDA Class 2 ·Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification
FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

FDA classification
FDA Not Classified ·Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Cultured Human Cell Skin Dressing

FDA classification
FDA Class 3 ·Cultured Human Cell Skin Dressing

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion

FDA classification
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion