GxPlex

FDA AI device list

FDA list of AI-enabled medical devices with marketing authorisation

not yet verified

Last verified: not yet verified Last observed: no observation recorded Tier: 1 · Sector: medical device

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Authority
US Food and Drug Administration
Jurisdiction
US
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
monthly
Crawlable
unknown
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov
Topics
artificial intelligence · medical devices · authorisation

Current status#

Status not yet verified against the primary source. Recorded as unknown rather than estimated.

Scope#

A dated and periodically extended list of artificial-intelligence-enabled medical devices that have received FDA marketing authorisation.

Key dates#

No dates have been verified against the primary source for this entry.

Sources#

NEEDS VERIFICATION. The regulatory status of this instrument has not yet been confirmed against its primary source. It is recorded as unknown rather than estimated. See /methodology for what verification means here.

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. FDA list of AI-enabled medical devices with marketing authorisation [instrument record]. Observed 27 July 2026. https://gxplex.com/instrument/fda-aiml-device-list Primary source: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

BibTeX

@misc{gxplexinstrumentfdaaimldevicelist,
  author       = {{GxPlex}},
  title        = {{FDA list of AI-enabled medical devices with marketing authorisation}},
  year         = {2026},
  note         = {instrument record, observed 27 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-aiml-device-list}},
  urldate      = {2026-07-28},
  url          = {https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices}
}

APA

GxPlex. (2026). FDA list of AI-enabled medical devices with marketing authorisation [instrument record]. Retrieved 27 July 2026, from https://gxplex.com/instrument/fda-aiml-device-list

Observation history

No observations recorded yet.

Sources