{"entity":{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","aka":["openFDA device data","FDA PMA database","FDA 510(k) database"],"tldr":"The FDA's public records of which medical devices and laboratory tests it has approved or cleared, when, and for what use.","summary":"The screening tests and receptor staining kits in this round were read from openFDA's device endpoints (pma, 510k and classification) on 4 November 2026, with the accessdata.fda.gov page consulted where the API was silent, for example the withdrawal date of a PMA or the classification name of a De Novo. A PMA approval order statement is the indication in the FDA's words, and the records quote it where it matters.","asOf":"2026-11-04","links":[{"label":"openFDA device API","url":"https://open.fda.gov/apis/device/"},{"label":"FDA PMA database","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm"}],"tags":[],"related":["cobas-hpv","bd-onclarity-hpv","aptima-hpv","alinity-m-hr-hpv","digene-hc2-hpv","teal-wand","thinprep","bd-surepath","automated-pap-screening-readers","genius-digital-diagnostics","cintec-plus-cytology","prostate-health-index","4kscore","isopsa","epi-procolon","oc-sensor-fit","nevisense","immunocyt","ventana-confirm-er-pr","dako-er-pr-ihc","leica-er-pr-ihc"],"cancers":[],"sections":["diagnostics","early-detection"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"url":"https://open.fda.gov/apis/device/","holds":"Every premarket approval (PMA) and its supplements with the approval order statement, every 510(k) clearance, De Novo classifications, and the product-code classification table, searchable on accessdata.fda.gov and through the openFDA API.","maintainer":"US Food and Drug Administration"},"route":"/collections/fda-device-databases/","neighbours":{"drug":[{"id":"4kscore","kind":"drug","name":"4Kscore Test (OPKO Health)","route":"/drugs/4kscore/"},{"id":"dako-er-pr-ihc","kind":"drug","name":"Agilent (Dako) ER and PR immunohistochemistry: ER/PR pharmDx, ER clone EP1, PR clones PgR 636 and PgR 1294","route":"/drugs/dako-er-pr-ihc/"},{"id":"alinity-m-hr-hpv","kind":"drug","name":"Alinity m HR HPV (Abbott)","route":"/drugs/alinity-m-hr-hpv/"},{"id":"aptima-hpv","kind":"drug","name":"Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay","route":"/drugs/aptima-hpv/"},{"id":"automated-pap-screening-readers","kind":"drug","name":"Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System","route":"/drugs/automated-pap-screening-readers/"},{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","route":"/drugs/bd-onclarity-hpv/"},{"id":"bd-surepath","kind":"drug","name":"BD SurePath liquid-based Pap test and PrepStain slide processor","route":"/drugs/bd-surepath/"},{"id":"cintec-plus-cytology","kind":"drug","name":"CINtec PLUS Cytology (p16/Ki-67 dual stain)","route":"/drugs/cintec-plus-cytology/"},{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/"},{"id":"digene-hc2-hpv","kind":"drug","name":"digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test","route":"/drugs/digene-hc2-hpv/"},{"id":"epi-procolon","kind":"drug","name":"Epi proColon (Septin 9 blood test for bowel cancer)","route":"/drugs/epi-procolon/"},{"id":"genius-digital-diagnostics","kind":"drug","name":"Genius Digital Diagnostics System with Genius Cervical AI (Hologic)","route":"/drugs/genius-digital-diagnostics/"},{"id":"immunocyt","kind":"drug","name":"ImmunoCyt (urine immunocytology for bladder cancer)","route":"/drugs/immunocyt/"},{"id":"isopsa","kind":"drug","name":"IsoPSA Assay (Cleveland Diagnostics)","route":"/drugs/isopsa/"},{"id":"leica-er-pr-ihc","kind":"drug","name":"Leica Biosystems ER clone 6F11 and PR clone 16 antibodies (Novocastra, BOND)","route":"/drugs/leica-er-pr-ihc/"},{"id":"nevisense","kind":"drug","name":"Nevisense (electrical impedance spectroscopy for melanoma, SciBase)","route":"/drugs/nevisense/"},{"id":"oc-sensor-fit","kind":"drug","name":"OC-Sensor faecal immunochemical tests (Eiken, Polymedco)","route":"/drugs/oc-sensor-fit/"},{"id":"prostate-health-index","kind":"drug","name":"Prostate Health Index (phi, Beckman Coulter)","route":"/drugs/prostate-health-index/"},{"id":"teal-wand","kind":"drug","name":"Teal Wand (home self-collection for HPV screening)","route":"/drugs/teal-wand/"},{"id":"thinprep","kind":"drug","name":"ThinPrep Pap Test and ThinPrep processors (Hologic)","route":"/drugs/thinprep/"},{"id":"ventana-confirm-er-pr","kind":"drug","name":"VENTANA CONFIRM anti-ER (SP1) and anti-PR (1E2) antibodies","route":"/drugs/ventana-confirm-er-pr/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}]}}