Raumedic AG is one of 467 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Raumedic AG - FDA 510(k) Cleared Devices
Recent clearances: NEUROVENT-P (092946-003), MPR2 logO DATALOGGER, RAUMEDIC-PTO-MONITORING-SYSTEM
6
Total
6
Cleared
0
Denied
Raumedic AG has 6 FDA 510(k) cleared medical devices. Based in Helmbrechts, DE.
Latest FDA clearance: Aug 2025. Active since 2011. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Raumedic AG Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Sud America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Raumedic AG
6 devices
Cleared
Aug 29, 2025
NEUROVENT-P (092946-003)
Neurology
210d
Cleared
Jul 06, 2017
MPR2 logO DATALOGGER
Neurology
31d
Cleared
Oct 25, 2013
RAUMEDIC-PTO-MONITORING-SYSTEM
Neurology
238d
Cleared
Apr 11, 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
Neurology
75d
Cleared
Oct 11, 2011
RAUMEDIC ICP MONITORING SYSTEM
Neurology
89d
Cleared
Mar 04, 2011
RAUMEDIC- ICP-MONITORING SYSTEM
Neurology
123d