512 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
FDA classification
FDA Class 2
·Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
FDA classification
FDA Class 2
·Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
FDA classification
FDA Class 2
·Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
FDA classification
FDA Class 2
·Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
FDA classification
FDA Class 2
·Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
FDA classification
FDA Class 2
·Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
FDA classification
FDA Class 2
·Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
FDA classification
FDA Class 2
·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
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
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
FDA classification
FDA Class 2
·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
FDA classification
FDA Class 2
·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings