Radi Medical Systems AB

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K123984	QUANTIEN MEASUREMENT SYSTEM	DQK	2013-03-28	View
510(k)	K092105	RADIANALYZER XPRESS	DQK	2009-10-09	View
510(k)	K080813	PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER	DXO	2008-07-01	View
510(k)	K080206	MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM	DXC	2008-02-26	View
510(k)	K062769	PRESSUREWIRE CERTUS, MODELS 12006 AND 12306	DXO	2006-12-04	View
510(k)	K042628	MODIFICATION TO: RADIANALYZER, MODEL 12711	DQK	2005-01-19	View
510(k)	K033291	TOPSEAL HEMOSTATIC DRESSING, MODEL 11150	QSY	2004-03-17	View
510(k)	K031662	PRESSURE WIRE SENSOR, MODELS 12004/12304	DXO	2003-06-06	View
510(k)	K024107	FEMOSTOP FEMORAL COMPRESSION SYSTEM	DXC	2002-12-24	View
510(k)	K022188	RADIANALYZER, MODEL 12710	DQK	2002-10-03	View
510(k)	K022187	PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304	DXO	2002-09-24	View
510(k)	K013943	RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720	DSK	2001-12-18	View
510(k)	K002067	RADIANALYZER, MODEL 12710	DSK	2001-01-11	View
510(k)	K002962	PRESSURE WIRE SENSOR, MODEL 12003/12303	DQX	2000-10-04	View
510(k)	K983471	FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER	DXC	1999-02-23	View
510(k)	K983506	PRESSUREWIRE SENSOR, MODEL #12001	DQX	1999-02-03	View
510(k)	K982182	FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0	DXC	1998-09-18	View
510(k)	K972793	PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE	DQX	1998-04-24	View
510(k)	K980898	FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER	DXC	1998-04-21	View
510(k)	K962425	BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)	GAA	1996-09-11	View