Light Source System, Diagnostic Endoscopic

FDA classification

FDA Class 3 ·Light Source System, Diagnostic Endoscopic

Complement C5, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C5, Antigen, Antiserum, Control

Light, Fiber Optic, Dental

FDA classification

FDA Class 1 ·Light, Fiber Optic, Dental

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

FDA classification

FDA Class 2 ·Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

FDA classification

FDA Class 2 ·Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA classification

FDA Class 2 ·Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification

FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

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

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Medical Glove, Specialty

FDA classification

FDA Class 1 ·Medical Glove, Specialty

Refractive Corneal Implant

FDA classification

Refractive Corneal Implant

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

FDA classification

FDA Class 2 ·Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Hospital Cardiac Telemetry

FDA classification

FDA Class 2 ·Hospital Cardiac Telemetry

Latex Patient Examination Glove

FDA classification

FDA Class 1 ·Latex Patient Examination Glove

Vinyl Patient Examination Glove

FDA classification

FDA Class 1 ·Vinyl Patient Examination Glove

Personal Lubricant Ring

FDA classification

FDA Class 2 ·Personal Lubricant Ring

Lubricant, Personal

FDA classification

FDA Class 2 ·Lubricant, Personal

Surgeon'S Gloves

FDA classification

FDA Class 1 ·Surgeon'S Gloves