# FDA medical device databases (PMA, 510(k), De Novo)

Source: https://onco.cc/collections/fda-device-databases/  
OnCo record `fda-device-databases` (Collection). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Collection
- Last checked: 2026-11-04
- Also known as: openFDA device data; FDA PMA database; FDA 510(k) database
- 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.

## Sources

- openFDA device API: https://open.fda.gov/apis/device/
- FDA PMA database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm

## Connected records

- drugs: [4Kscore Test (OPKO Health)](https://onco.cc/drugs/4kscore/), [Agilent (Dako) ER and PR immunohistochemistry: ER/PR pharmDx, ER clone EP1, PR clones PgR 636 and PgR 1294](https://onco.cc/drugs/dako-er-pr-ihc/), [Alinity m HR HPV (Abbott)](https://onco.cc/drugs/alinity-m-hr-hpv/), [Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay](https://onco.cc/drugs/aptima-hpv/), [Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System](https://onco.cc/drugs/automated-pap-screening-readers/), [BD Onclarity HPV Assay (extended genotyping)](https://onco.cc/drugs/bd-onclarity-hpv/), [BD SurePath liquid-based Pap test and PrepStain slide processor](https://onco.cc/drugs/bd-surepath/), [CINtec PLUS Cytology (p16/Ki-67 dual stain)](https://onco.cc/drugs/cintec-plus-cytology/), [cobas HPV test (Roche)](https://onco.cc/drugs/cobas-hpv/), [digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test](https://onco.cc/drugs/digene-hc2-hpv/), [Epi proColon (Septin 9 blood test for bowel cancer)](https://onco.cc/drugs/epi-procolon/), [Genius Digital Diagnostics System with Genius Cervical AI (Hologic)](https://onco.cc/drugs/genius-digital-diagnostics/), [ImmunoCyt (urine immunocytology for bladder cancer)](https://onco.cc/drugs/immunocyt/), [IsoPSA Assay (Cleveland Diagnostics)](https://onco.cc/drugs/isopsa/), [Leica Biosystems ER clone 6F11 and PR clone 16 antibodies (Novocastra, BOND)](https://onco.cc/drugs/leica-er-pr-ihc/), [Nevisense (electrical impedance spectroscopy for melanoma, SciBase)](https://onco.cc/drugs/nevisense/), [OC-Sensor faecal immunochemical tests (Eiken, Polymedco)](https://onco.cc/drugs/oc-sensor-fit/), [Prostate Health Index (phi, Beckman Coulter)](https://onco.cc/drugs/prostate-health-index/), [Teal Wand (home self-collection for HPV screening)](https://onco.cc/drugs/teal-wand/), [ThinPrep Pap Test and ThinPrep processors (Hologic)](https://onco.cc/drugs/thinprep/), [VENTANA CONFIRM anti-ER (SP1) and anti-PR (1E2) antibodies](https://onco.cc/drugs/ventana-confirm-er-pr/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)

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JSON: https://onco.cc/api/v1/entities/fda-device-databases.json