Radi Medical Systems AB - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
21 devices
Cleared
Mar 28, 2013
QUANTIEN MEASUREMENT SYSTEM
Cardiovascular
92d
Cleared
Oct 09, 2009
RADIANALYZER XPRESS
Cardiovascular
87d
Cleared
Jul 01, 2008
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
Cardiovascular
102d
Cleared
Feb 26, 2008
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
Cardiovascular
29d
Cleared
Dec 04, 2006
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
Cardiovascular
80d
Cleared
Jan 19, 2005
MODIFICATION TO: RADIANALYZER, MODEL 12711
Cardiovascular
114d
Cleared
Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
Cardiovascular
9d
Cleared
Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
Cardiovascular
11d
Cleared
Oct 03, 2002
RADIANALYZER, MODEL 12710
Cardiovascular
90d
Cleared
Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
Cardiovascular
81d
Cleared
Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
Cardiovascular
19d
Cleared
Jan 11, 2001
RADIANALYZER, MODEL 12710
Cardiovascular
188d