Company ยท FI
Planmed OY
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2025. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 2025 | K250318 | Planmed XFI Planmed OY, FI | SFV |
| Jul 18, 2022 | K211720 | Planmed Clarity 2D, Planmed Clarify S Planmed OY, FI | MUE |
| Apr 28, 2022 | K213278 | Planmed Verity Planmed OY, FI | OAS |
| Oct 23, 2020 | K192317 | Planmed Clarity 2D and Clarity S Planmed OY, FI | MUE |
| Nov 30, 2018 | K180918 | Planmed Verity Planmed OY, FI | OAS |
| Dec 28, 2017 | K163328 | Planmed Clarity Planmed OY, FI | MUE |
| May 14, 2015 | K143435 | Planmed Verity Planmed OY, FI | OAS |
| Feb 1, 2013 | K121418 | PLANMED VERITY Planmed OY, FI | JAK |
| Nov 21, 2012 | K121963 | PLANMED NUANCE DIGIGUIDE Planmed OY, FI | MUE |
| Nov 19, 2004 | K042671 | PLANMED SOPHIE NUANCE CLASSIC Planmed OY | IZH |
| Feb 21, 2003 | K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) Planmed OY | IZH |
| Jan 16, 2002 | K013656 | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC Planmed OY | IZH |
| Mar 15, 2001 | K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC Planmed OY | IZH |
| Aug 10, 1999 | K991826 | PLANMED SOPHIE AND SOPHIE CLASSIC Planmed OY | IZH |
| Nov 16, 1998 | K983659 | PLANMED SOPHIE & PLANNED SOPHIE CLASSIC Planmed OY, FI | IZH |
| Nov 10, 1997 | K973493 | PLANMED CYTOGUIDE Planmed OY | IZH |
| Feb 5, 1997 | K962105 | PLANNED SOPHIED CLASSIC Planmed OY, FI | IZH |
| May 24, 1995 | K951883 | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT Planmed OY, FI | IZH |
| Apr 7, 1994 | K934373 | MOBILE SOPHIE MODIFICATION Planmed OY, FI | IZH |
| Nov 24, 1992 | K923471 | PLANMED CYTOGUIDE Planmed OY, FI | IZH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||