Class II/III Devices
Software as a Medical Device (SaMD)
Cardiology Medical Imaging Systems
Artificial Intelligence
Abnormal blood cell analysis
Pathology scanning/cloud tech devices
In Vitro Diagnostic Kits
Cardiovascular
Infectious disease
Immunochromatography
Radioisotopic
Glucose monitoring
Gene therapy
Cardiology
Enzymatic
Elisa
Biomarkers
Proteomics
Proteomic IVD for clinical diagnosis (PMA)
Hemostatic devices
Extracorporeal
Topical
Dental
Drug delivery devices
Topical
Intravascular
Nasal spray
Aneurysm embolization devices
[510(k)], PMA
Glucometer for monitoring diabetes control
Left Ventricular Assist Devices (LVAD)
Intravascular stents (neuro)
Glaucoma diagnosis
Scalar wave devices
Implants
Orthopedic
Spinal
Cochlear
Dental (multiple varieties of implants,
abutments and associated tools)
Grafts
Yttrium containing microbeads for treatment
of liver cancer (PMA)
Ophthalmic perimetry, scanning, and retinal
examination devices
Arteriovenous malformation treatment devices
PCA “pain” pumps
Unique suture materials
Catheters (cardiology, neuroradiology)
Femoral artery closure devices
(used after angioplasty)
Sleep apnea diagnosis/monitoring
Electronic Devices with Disposables
IV pumps/delivery sets
Pulse oximetry devices and sensors
Cardiovascular monitoring devices
Sleep apnea devices/administration equipment
Programmable pumps for diabetics/disposables
Glucose monitoring (including implanted
sensors)
Automatic blood pressure measurement
Electronic thermometers
Treatment device for diabetic foot ulcers
Visual field defect devices
Ventilators
Medical Adhesives
Tissue glues
Spinal devices
Wound healing devices (closure devices, artificial skin grafts, tissue adhesives)