CPS ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

Device, Antichoke, Suction

FDA classification

FDA Class 3 ·Device, Antichoke, Suction

Device, Antichoke, Tongs

FDA classification

FDA Class 3 ·Device, Antichoke, Tongs

Stimulator, Transdermal

FDA classification

FDA Class 3 ·Stimulator, Transdermal

Polymer, Natural-Absorbable Gelatin Material

FDA classification

FDA Class 3 ·Polymer, Natural-Absorbable Gelatin Material

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA classification

FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Partially Implanted

Tympanostomy Tube Delivery Product With Drug

FDA classification

FDA Class 3 ·Tympanostomy Tube Delivery Product With Drug

Drug-Eluting Sinus Stent

FDA classification

FDA Class 3 ·Drug-Eluting Sinus Stent

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification

FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA classification

FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Totally Implanted

Implant, Auditory Brainstem

FDA classification

FDA Class 3 ·Implant, Auditory Brainstem

Implant, Cochlear

FDA classification

FDA Class 3 ·Implant, Cochlear

System, Imaging, Fluorescence

FDA classification

FDA Class 3 ·System, Imaging, Fluorescence

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·Inform HER2 Dual ISH DNA Probe Cocktail

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Low Porosity Valved Conduit

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t)