10 results · 40ms · Sources: EU EUDAMED, US FDA

Test Reagents, Neisseria Gonorrhoeae Biochemical

FDA classification
FDA Class 1 ·Test Reagents, Neisseria Gonorrhoeae Biochemical

Tube, Bronchial (W/Wo Connector)

FDA classification
FDA Class 2 ·Tube, Bronchial (W/Wo Connector)

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

FDA classification
FDA Class 2 ·Sucker, Cardiotomy Return, Cardiopulmonary Bypass

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

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

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, 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

Over-The-Counter Automated External Defibrillator

FDA classification
FDA Class 3 ·Over-The-Counter Automated External Defibrillator