title: What does "FDA Approved" mean for medical devices?
authors.forename: Ingrid
authors.initials: I
authors.lastname: Nygaard
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004868:Equipment Failure; D005260:Female; D006176:Gynecology; D006801:Humans; D019221:Mandatory Reporting; D009774:Obstetrics; D014481:United States; D014486:United States Food and Drug Administration