Planmed OY
FDA 510(k) & PMA Approved Devices — 19 products
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Total Devices19
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K250318 | Planmed XFI | SFV | 2025-09-26 | View |
| 510(k) | K211720 | Planmed Clarity 2D, Planmed Clarify S | MUE | 2022-07-18 | View |
| 510(k) | K213278 | Planmed Verity | OAS | 2022-04-28 | View |
| 510(k) | K192317 | Planmed Clarity 2D and Clarity S | MUE | 2020-10-23 | View |
| 510(k) | K180918 | Planmed Verity | OAS | 2018-11-30 | View |
| 510(k) | K163328 | Planmed Clarity | MUE | 2017-12-28 | View |
| 510(k) | K121418 | PLANMED VERITY | JAK | 2013-02-01 | View |
| 510(k) | K121963 | PLANMED NUANCE DIGIGUIDE | MUE | 2012-11-21 | View |
| 510(k) | K042671 | PLANMED SOPHIE NUANCE CLASSIC | IZH | 2004-11-19 | View |
| 510(k) | K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) | IZH | 2003-02-21 | View |
| 510(k) | K013656 | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC | IZH | 2002-01-16 | View |
| 510(k) | K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC | IZH | 2001-03-15 | View |
| 510(k) | K991826 | PLANMED SOPHIE AND SOPHIE CLASSIC | IZH | 1999-08-10 | View |
| 510(k) | K983659 | PLANMED SOPHIE & PLANNED SOPHIE CLASSIC | IZH | 1998-11-16 | View |
| 510(k) | K973493 | PLANMED CYTOGUIDE | IZH | 1997-11-10 | View |
| 510(k) | K962105 | PLANNED SOPHIED CLASSIC | IZH | 1997-02-05 | View |
| 510(k) | K951883 | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT | IZH | 1995-05-24 | View |
| 510(k) | K934373 | MOBILE SOPHIE MODIFICATION | IZH | 1994-04-07 | View |
| 510(k) | K923471 | PLANMED CYTOGUIDE | IZH | 1992-11-24 | View |
No matching devices.
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