Device classification

Records

• Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

  Cardiovascular · 21 CFR 870.1251

  Class IIProduct code PUM
  FDA page
• Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

  Ophthalmic · 21 CFR 886.4100

  Class IIProduct code PUL
  FDA page
• System, Automated Platelet Aggregation

  Hematology · 21 CFR 864.5700

  Class IIProduct code JOZ
  FDA page
• Hemodialysis Tray (Not A Start/Stop Kit)

  Gastroenterology, Urology · 21 CFR 876.5820

  Class IIProduct code PPI
  FDA page
• Restoration, Noble Metal

  Unknown

  Not classifiedProduct code NSJ
  FDA page
• Esthesiometer, Ocular

  Ophthalmic · 21 CFR 886.1040

  Class IProduct code HJCExempt
  FDA page
• Rasp

  General, Plastic Surgery · 21 CFR 878.4800

  Class IProduct code HTRExempt
  FDA page
• Turbidimetric Method, Globulin

  Clinical Chemistry · 21 CFR 862.1330

  Class IProduct code JGEExempt
  FDA page
• 2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)

  Clinical Chemistry · 21 CFR 862.1515

  Class IProduct code JMWExempt
  FDA page
• Valve, Switching (Ploss)

  Anesthesiology · 21 CFR 868.1965

  Class IProduct code JFEExempt
  FDA page
• System, Applicator, Radionuclide, Remote-Controlled

  Radiology · 21 CFR 892.5700

  Class IIProduct code JAQ
  FDA page
• Whole Blood Hemoglobin Determination

  Hematology · 21 CFR 864.7500

  Class IIProduct code KHG
  FDA page
• Patient Specific Manual Orthopedic Stereotaxic System

  Neurology · 21 CFR 882.4560

  Class IIProduct code OSF
  FDA page
• Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

  Microbiology · 21 CFR 866.3172

  Class IIProduct code LOM
  FDA page
• Mattress, Water, Temperature Regulated

  General Hospital · 21 CFR 880.5560

  Class IProduct code FOHExempt
  FDA page
• Reagents, 2019-Novel Coronavirus Nucleic Acid

  Unknown

  Not classifiedProduct code QJR
  FDA page
• Autoantibodies, Glutamic Acid Decarboxylase (Gad)

  Immunology · 21 CFR 866.5660

  Class IIProduct code NWG
  FDA page
• Optical Coherence Tomography, Intravascular Catheter

  Cardiovascular · 21 CFR 870.1200

  Class IIProduct code ORD
  FDA page
• Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms

  Neurology · 21 CFR 882.5807

  Class IIProduct code SHX
  FDA page
• System, Gastrointestinal Motility (Electrical)

  Gastroenterology, Urology · 21 CFR 876.1725

  Class IIProduct code FFX
  FDA page