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
  Infectious disease
  Glucose monitoring
  Gene therapy
  Proteomic IVD for clinical diagnosis (PMA)

Hemostatic devices

Drug delivery devices
  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
    Dental (multiple varieties of implants,
    abutments and associated tools)
    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
  Automatic blood pressure measurement
  Electronic thermometers
  Treatment device for diabetic foot ulcers
  Visual field defect devices

Medical Adhesives
Tissue glues
Spinal devices
Wound healing devices (closure devices, artificial skin grafts, tissue adhesives)