Device classification

Records

• Protector, Hearing (Circumaural)

  Unknown

  UnclassifiedProduct code EWE
  FDA page
• Intervertebral Fusion Device With Bone Graft, Thoracic

  Orthopedic · 21 CFR 888.3080

  Class IIProduct code PHM
  FDA page
• Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive

  Unknown

  Class IIIProduct code HTM
  FDA page
• Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic

  Hematology · 21 CFR 864.7360

  Class IIProduct code JBK
  FDA page
• Respiratory Syncytial Virus, Antigen, Antibody, Ifa

  Microbiology · 21 CFR 866.3480

  Class IProduct code LKTExempt
  FDA page
• Brush, Dermabrasion, Powered

  General, Plastic Surgery · 21 CFR 878.4820

  Class IProduct code GFEExempt
  FDA page
• System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

  Unknown

  Class IIIProduct code MTE
  FDA page
• Maxwell Spot, Ac-Powered

  Ophthalmic · 21 CFR 886.1435

  Class IProduct code HIXExempt
  FDA page
• Radioimmunoassay, Human Growth Hormone

  Clinical Chemistry · 21 CFR 862.1370

  Class IProduct code CFLExempt
  FDA page
• Radiological Computer-Assisted Triage And Notification Software

  Radiology · 21 CFR 892.2080

  Class IIProduct code QAS
  FDA page
• Intracranial Pressure & Temperature Monitoring Kit

  Neurology · 21 CFR 882.1620

  Class IIProduct code PSP
  FDA page
• Cabinet, Ethylene-Oxide Gas Aerator

  General Hospital · 21 CFR 880.6100

  Class IIProduct code FLI
  FDA page
• Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

  General, Plastic Surgery · 21 CFR 878.4015

  Class IIProduct code NYS
  FDA page
• Test, Donor, Cmv

  Unknown

  Class IIProduct code MZE
  FDA page
• Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

  Unknown

  Class IIIProduct code MYL
  FDA page
• Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

  Neurology · 21 CFR 882.1440

  Class IIProduct code NCG
  FDA page
• Multivariate Vital Signs Index

  Cardiovascular · 21 CFR 870.2300

  Class IIProduct code PLB
  FDA page
• Amalgamator, Dental, Ac-Powered

  Dental · 21 CFR 872.3100

  Class IProduct code EFDExempt
  FDA page
• Table, Physical Therapy, Multi Function

  Physical Medicine · 21 CFR 890.5880

  Class IIProduct code JFB
  FDA page
• Staple, Implantable

  General, Plastic Surgery · 21 CFR 878.4750

  Class IIProduct code GDW
  FDA page