Company ยท SE
Radi Medical Systems AB
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2013. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXC | Clamp, Vascular | 8 |
| DQK | Computer, Diagnostic, Programmable | 4 |
| DXO | Transducer, Pressure, Catheter Tip | 4 |
| DQX | Wire, Guide, Catheter | 3 |
| DSK | Computer, Blood-Pressure | 2 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2013 | K123984 | QUANTIEN MEASUREMENT SYSTEM Radi Medical Systems AB, SE | DQK |
| Oct 9, 2009 | K092105 | RADIANALYZER XPRESS Radi Medical Systems AB, SE | DQK |
| Jul 1, 2008 | K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER Radi Medical Systems AB, SE | DXO |
| Feb 26, 2008 | K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM Radi Medical Systems AB, SE | DXC |
| Dec 4, 2006 | K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 Radi Medical Systems AB, SE | DXO |
| Jan 19, 2005 | K042628 | MODIFICATION TO: RADIANALYZER, MODEL 12711 Radi Medical Systems AB, SE | DQK |
| Mar 17, 2004 | K033291 | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 Radi Medical Systems AB, SE | QSY |
| Jun 6, 2003 | K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 Radi Medical Systems AB, SE | DXO |
| Dec 24, 2002 | K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM Radi Medical Systems AB, SE | DXC |
| Oct 3, 2002 | K022188 | RADIANALYZER, MODEL 12710 Radi Medical Systems AB, SE | DQK |
| Sep 24, 2002 | K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 Radi Medical Systems AB, SE | DXO |
| Dec 18, 2001 | K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 Radi Medical Systems AB, SE | DSK |
| Jan 11, 2001 | K002067 | RADIANALYZER, MODEL 12710 Radi Medical Systems AB, SE | DSK |
| Oct 4, 2000 | K002962 | PRESSURE WIRE SENSOR, MODEL 12003/12303 Radi Medical Systems AB, SE | DQX |
| Feb 23, 1999 | K983471 | FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER Radi Medical Systems AB, SE | DXC |
| Feb 3, 1999 | K983506 | PRESSUREWIRE SENSOR, MODEL #12001 Radi Medical Systems AB, SE | DQX |
| Sep 18, 1998 | K982182 | FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 Radi Medical Systems AB, SE | DXC |
| Apr 24, 1998 | K972793 | PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE Radi Medical Systems AB, SE | DQX |
| Apr 21, 1998 | K980898 | FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER Radi Medical Systems AB, SE | DXC |
| Sep 11, 1996 | K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) Radi Medical Systems AB, SE | GAA |
| Oct 27, 1995 | K954669 | FEMOSTOP, FEMOSTOP PUMP Radi Medical Systems AB, SE | DXC |
| Jul 20, 1995 | K944259 | FEMOSTOP II Radi Medical Systems AB, SE | DXC |
| Apr 22, 1992 | K915280 | FEMOSTOP Radi Medical Systems AB, SE | DXC |
| Oct 29, 1990 | K903622 | CT GUIDE (TM) Radi Medical Systems AB, SE | JAK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||