199 results · 43ms · Sources: EU EUDAMED, US FDA

Stimulator, Bone Growth, Non-Invasive

FDA classification
FDA Class 3 ·Stimulator, Bone Growth, Non-Invasive

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Lead, Atomic Absorption

FDA classification
FDA Class 2 ·Lead, Atomic Absorption

Antisera, Neutralization, Poliovirus 1-3

FDA classification
FDA Class 1 ·Antisera, Neutralization, Poliovirus 1-3

Ldt, Approved By Nys Clep

FDA classification
FDA Not Classified ·Ldt, Approved By Nys Clep

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification
FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

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

Laparoscope, General & Plastic Surgery

FDA classification
FDA Class 2 ·Laparoscope, General & Plastic Surgery

Arthroscope

FDA classification
FDA Class 2 ·Arthroscope

Electrosurgical, Cutting & Coagulation & Accessories

FDA classification
FDA Class 2 ·Electrosurgical, Cutting & Coagulation & Accessories

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification
FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

FDA classification
FDA Class 2 ·Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Spectacle Microscope, Low-Vision

FDA classification
FDA Class 1 ·Spectacle Microscope, Low-Vision

Diagnostic Low Electric Field

FDA classification
FDA Class 3 ·Diagnostic Low Electric Field

Lipoprotein, Low Density, Removal

FDA classification
FDA Class 3 ·Lipoprotein, Low Density, Removal

Loupe, Binocular, Low Power

FDA classification
FDA Class 1 ·Loupe, Binocular, Low Power

Telescope, Spectacle, Low-Vision

FDA classification
FDA Class 1 ·Telescope, Spectacle, Low-Vision

Telescope, Hand-Held, Low-Vision

FDA classification
FDA Class 1 ·Telescope, Hand-Held, Low-Vision

System, Test, Low Density, Lipoprotein

FDA classification
FDA Class 1 ·System, Test, Low Density, Lipoprotein

Low Dead Space Piston Syringe

FDA classification
FDA Class 2 ·Low Dead Space Piston Syringe