Planmed Oy
Helsinki Uusimaa, FI
Planmed Oy appears in FDA device records in Helsinki Uusimaa, FI. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Planmed Oy between 1992 and 2025. The busiest year on record is 1997, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250318 | Planmed XFI | SFV | Substantially Equivalent | |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | MUE | Substantially Equivalent | |
| K213278 | Planmed Verity | OAS | Substantially Equivalent | |
| K192317 | Planmed Clarity 2D and Clarity S | MUE | Substantially Equivalent | |
| K180918 | Planmed Verity | OAS | Substantially Equivalent | |
| K163328 | Planmed Clarity | MUE | Substantially Equivalent | |
| K143435 | Planmed Verity | OAS | Substantially Equivalent | |
| K121418 | PLANMED VERITY | JAK | Substantially Equivalent | |
| K121963 | PLANMED NUANCE DIGIGUIDE | MUE | Substantially Equivalent | |
| K042671 | PLANMED SOPHIE NUANCE CLASSIC | IZH | Substantially Equivalent | |
| K021945 | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) | IZH | Substantially Equivalent | |
| K013656 | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC | IZH | Substantially Equivalent | |
| K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC | IZH | Substantially Equivalent | |
| K991826 | PLANMED SOPHIE AND SOPHIE CLASSIC | IZH | Substantially Equivalent | |
| K983659 | PLANMED SOPHIE & PLANNED SOPHIE CLASSIC | IZH | Substantially Equivalent | |
| K973493 | PLANMED CYTOGUIDE | IZH | Substantially Equivalent | |
| K962105 | PLANNED SOPHIED CLASSIC | IZH | Substantially Equivalent | |
| K951883 | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT | IZH | Substantially Equivalent | |
| K934373 | MOBILE SOPHIE MODIFICATION | IZH | Substantially Equivalent | |
| K923471 | PLANMED CYTOGUIDE | IZH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043728 | 3002807903 | Planmed Oy | Sorvaajankatu 7, Helsinki Uusimaa 00880 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain