17 results · 37ms · Sources: EU EUDAMED, US FDA

Cap, Bone

FDA classification
FDA Class 1 ·Cap, Bone

Lavage, Jet

FDA classification
FDA Class 2 ·Lavage, Jet

Keratome, Water Jet

FDA classification
FDA Class 1 ·Keratome, Water Jet

Crimper, Wire, Ent, Non-Sterile

FDA classification
FDA Class 1 ·Crimper, Wire, Ent, Non-Sterile

Fluid Jet Removal System

FDA classification
FDA Class 2 ·Fluid Jet Removal System

Injector, Jet, Mechanical-Powered

FDA classification
FDA Class 2 ·Injector, Jet, Mechanical-Powered

Injector, Jet, Gas-Powered

FDA classification
FDA Class 2 ·Injector, Jet, Gas-Powered

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA classification
FDA Class 1 ·Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

Ldt, Approved By Nys Clep

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

System, Water Jet Catheter, Renal

FDA classification
FDA Class 2 ·System, Water Jet Catheter, Renal

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

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

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

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

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