55 results · 39ms · Sources: EU EUDAMED, US FDA

Splint, Intranasal Septal

FDA classification
FDA Class 1 ·Splint, Intranasal Septal

Camera, Ophthalmic, Non-Prescription

FDA classification
FDA Class 2 ·Camera, Ophthalmic, Non-Prescription

Gown, Surgical

FDA classification
FDA Class 2 ·Gown, Surgical

Stylet, Ureteral

FDA classification
FDA Class 1 ·Stylet, Ureteral

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

Scissors, Wire Cutting, Ent, Non-Sterile

FDA classification
FDA Class 1 ·Scissors, Wire Cutting, Ent, Non-Sterile

Biological Sterilization Indicator With Indirect Growth Detection

FDA classification
FDA Class 2 ·Biological Sterilization Indicator With Indirect Growth Detection

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

Sponge, Eyelid Cleaning, Powered

FDA classification
FDA Class 1 ·Sponge, Eyelid Cleaning, Powered

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

Non-Normalizing Quantitative Electroencephalograph Software

FDA classification
FDA Class 2 ·Non-Normalizing Quantitative Electroencephalograph Software

Normalizing Quantitative Electroencephalograph Software

FDA classification
FDA Class 2 ·Normalizing Quantitative Electroencephalograph Software

Sheet, Recording, Breast Examination

FDA classification
FDA Class 2 ·Sheet, Recording, Breast Examination

Endoscopic Morcellator Gastroenterology

FDA classification
FDA Class 2 ·Endoscopic Morcellator Gastroenterology

Index-Generating Electroencephalograph Software

FDA classification
FDA Class 2 ·Index-Generating Electroencephalograph Software

Fall Prevention Alarm/Sensor Attached Only

FDA classification
FDA Class 1 ·Fall Prevention Alarm/Sensor Attached Only

Smart Meter

FDA classification
FDA Not Classified ·Smart Meter

Cranial Measurement Software

FDA classification
FDA Class 1 ·Cranial Measurement Software

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

FDA classification
FDA Class 2 ·Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

Immunocytochemistry Assay, P16/Ki-67

FDA classification
FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67