General Electric Company is one of 21491 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
General Electric Company - FDA 510(k) Cleared Devices
Recent clearances: SENOGRAPHE DS, SENOGRAPHE ESSENTIAL, SENOGRAPH DS, SENOGRAPH ESSENSTIAL
2
Total
2
Cleared
0
Denied
General Electric Company, is a diversified industrial conglomerate with a manufacturing facility in Waukesha, US. The company has spun into three standalone public entities: GE Aerospace, GE Vernova, and GE HealthCare, each serving distinct markets globally.
In the medical device sector, General Electric Company received 2 FDA 510(k) clearances from 2 total submissions. The company's regulatory activity in this space focused on Radiology devices, with clearances granted between 2011 and 2011. This represents a historical regulatory record; no new clearances have been issued in more than a decade.
The cleared devices included imaging systems designed for diagnostic radiology applications. For detailed information on specific device names, product codes, and clearance dates, please review the full submission history.
FDA 510(k) Regulatory Record - General Electric Company
2 devices