369 results
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41ms
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Sources: EU EUDAMED, US FDA
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Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
FDA classification
FDA Class 2
·Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
Permanent Defibrillator Electrodes
FDA classification
FDA Class 3
·Permanent Defibrillator Electrodes
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
FDA classification
FDA Class 3
·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule
FDA classification
FDA Not Classified
·Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule
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
Orthosis, Cranial, Laser Scan
FDA classification
FDA Class 2
·Orthosis, Cranial, Laser Scan
Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
FDA classification
FDA Not Classified
·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
FDA classification
FDA Not Classified
·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule