Radi Medical Systems AB
Uppsala, SE
Radi Medical Systems AB appears in FDA device records in Uppsala, SE. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Radi Medical Systems AB between 1990 and 2013. The busiest year on record is 1998, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1992 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123984 | QUANTIEN MEASUREMENT SYSTEM | DQK | Substantially Equivalent | |
| K092105 | RADIANALYZER XPRESS | DQK | Substantially Equivalent | |
| K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER | DXO | Substantially Equivalent | |
| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | DXC | Substantially Equivalent | |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | DXO | Substantially Equivalent | |
| K042628 | MODIFICATION TO: RADIANALYZER, MODEL 12711 | DQK | Substantially Equivalent | |
| K033291 | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 | QSY | Substantially Equivalent | |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | DXO | Substantially Equivalent | |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | DXC | Substantially Equivalent | |
| K022188 | RADIANALYZER, MODEL 12710 | DQK | Substantially Equivalent | |
| K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | DXO | Substantially Equivalent | |
| K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | DSK | Substantially Equivalent | |
| K002067 | RADIANALYZER, MODEL 12710 | DSK | Substantially Equivalent | |
| K002962 | PRESSURE WIRE SENSOR, MODEL 12003/12303 | DQX | Substantially Equivalent | |
| K983471 | FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER | DXC | Substantially Equivalent | |
| K983506 | PRESSUREWIRE SENSOR, MODEL #12001 | DQX | Substantially Equivalent | |
| K982182 | FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 | DXC | Substantially Equivalent | |
| K972793 | PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE | DQX | Substantially Equivalent | |
| K980898 | FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER | DXC | Substantially Equivalent | |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | GAA | Substantially Equivalent | |
| K954669 | FEMOSTOP, FEMOSTOP PUMP | DXC | Substantially Equivalent | |
| K944259 | FEMOSTOP II | DXC | Substantially Equivalent | |
| K915280 | FEMOSTOP | DXC | Substantially Equivalent | |
| K903622 | CT GUIDE (TM) | JAK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain