Rapid Biomedical GmbH is one of 470 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Rapid Biomedical GmbH - FDA 510(k) Cleared Devices
Recent clearances: 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil, 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support, 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
7
Total
7
Cleared
0
Denied
Rapid Biomedical GmbH has 7 FDA 510(k) cleared medical devices. Based in Rimpar, DE.
Last cleared in 2023. Active since 2008. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Rapid Biomedical GmbH Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Rapid Biomedical GmbH
7 devices
Cleared
Feb 01, 2023
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
Radiology
460d
Cleared
Jan 31, 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
Radiology
235d
Cleared
Nov 16, 2018
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
Radiology
119d
Cleared
Mar 21, 2018
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
Radiology
449d
Cleared
May 13, 2011
31P/1H HEAD COIL 3T
Radiology
232d
Cleared
Dec 22, 2010
31P/1H DUAL TUNED SURFACE COIL 3T
Radiology
125d
Cleared
Nov 21, 2008
16CH AI BREAST COILS 1.5 T AND 3 T
Radiology
17d