Medical Device Manufacturer · SE , Uppsala

Radi Medical Systems AB - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1990
24
Total
24
Cleared
0
Denied

Radi Medical Systems AB has 24 FDA 510(k) cleared cardiovascular devices. Based in Uppsala, SE.

Historical record: 24 cleared submissions from 1990 to 2013.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Radi Medical Systems AB
24 devices
1-24 of 24
Cleared Mar 28, 2013
QUANTIEN MEASUREMENT SYSTEM
K123984 · DQK
Cardiovascular · 92d
Cleared Oct 09, 2009
RADIANALYZER XPRESS
K092105 · DQK
Cardiovascular · 87d
Cleared Jul 01, 2008
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · DXO
Cardiovascular · 102d
Cleared Feb 26, 2008
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · DXC
Cardiovascular · 29d
Cleared Dec 04, 2006
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · DXO
Cardiovascular · 80d
Cleared Jan 19, 2005
MODIFICATION TO: RADIANALYZER, MODEL 12711
K042628 · DQK
Cardiovascular · 114d
Cleared Mar 17, 2004
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · QSY
General & Plastic Surgery · 155d
Cleared Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · DXO
Cardiovascular · 9d
Cleared Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · DXC
Cardiovascular · 11d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · DQK
Cardiovascular · 90d
Cleared Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · DXO
Cardiovascular · 81d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · DSK
Cardiovascular · 19d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067 · DSK
Cardiovascular · 188d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · DQX
Cardiovascular · 12d
Cleared Feb 23, 1999
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K983471 · DXC
Cardiovascular · 144d
Cleared Feb 03, 1999
PRESSUREWIRE SENSOR, MODEL #12001
K983506 · DQX
Cardiovascular · 119d
Cleared Sep 18, 1998
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION...
K982182 · DXC
Cardiovascular · 88d
Cleared Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR...
K972793 · DQX
Cardiovascular · 270d
Cleared Apr 21, 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP,...
K980898 · DXC
Cardiovascular · 43d
Cleared Sep 11, 1996
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
K962425 · GAA
General & Plastic Surgery · 79d
Cleared Oct 27, 1995
FEMOSTOP, FEMOSTOP PUMP
K954669 · DXC
Cardiovascular · 17d
Cleared Jul 20, 1995
FEMOSTOP II
K944259 · DXC
Cardiovascular · 322d
Cleared Apr 22, 1992
FEMOSTOP
K915280 · DXC
Cardiovascular · 149d
Cleared Oct 29, 1990
CT GUIDE (TM)
K903622 · JAK
Radiology · 81d
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