Geratherm AG is one of 25752 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Geratherm AG - FDA 510(k) Cleared Devices
Recent clearances: GERATHERM BABYWATCH TEMPERATURE MONITOR
1
Total
1
Cleared
0
Denied
Geratherm AG, is an international medical device manufacturer specializing in innovative healthcare solutions. The company operates with a manufacturing facility in Southfield, US, and maintains operations across multiple countries including Germany and Brazil.
Geratherm received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on General Hospital devices. The cleared device, GERATHERM BABYWATCH TEMPERATURE MONITOR, was approved in 2001. The company is currently inactive with no FDA submissions in over five years and should be treated as a historical regulatory record.
Based on available product information, Geratherm's portfolio encompasses temperature measurement devices, blood pressure monitors, respiratory therapy equipment, oxygen measurement systems, and specialized diagnostic solutions. The company historically served both consumer and professional healthcare markets including clinics, practices, and emergency services.
Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.
FDA 510(k) Regulatory Record - Geratherm AG
1 devices