20 results · 23ms · Sources: EU EUDAMED, US FDA

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, 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

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

Gowns And Other Apparel

FDA classification
FDA Not Classified ·Gowns And Other Apparel

General Wellness Product

FDA classification
FDA Not Classified ·General Wellness Product

Eua Faceshields

FDA classification
FDA Not Classified ·Eua Faceshields

System, Transdermal Delivery, Cder Or Cber Led

FDA classification
FDA Not Classified ·System, Transdermal Delivery, Cder Or Cber Led

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

FDA classification
FDA Not Classified ·Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

Decontamination Systems For N95 Respirators

FDA classification
FDA Not Classified ·Decontamination Systems For N95 Respirators

Mask, Surgical, Eua Authorized

FDA classification
FDA Not Classified ·Mask, Surgical, Eua Authorized

Protective Barrier Enclosure With Negative Pressure

FDA classification
FDA Not Classified ·Protective Barrier Enclosure With Negative Pressure

Lockbox (Export Only)

FDA classification
FDA Not Classified ·Lockbox (Export Only)

Nasal Spray, Systemic Delivery, Cder Or Cber Led

FDA classification
FDA Not Classified ·Nasal Spray, Systemic Delivery, Cder Or Cber Led

Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

FDA classification
FDA Not Classified ·Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

FDA classification
FDA Not Classified ·Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Material, Implantable For Controlled Release, Cder Or Cber Led

FDA classification
FDA Not Classified ·Material, Implantable For Controlled Release, Cder Or Cber Led

Anti-Stick Glass Syringe

FDA classification
FDA Not Classified ·Anti-Stick Glass Syringe

Protective Barrier Enclosure

FDA classification
FDA Not Classified ·Protective Barrier Enclosure