Planmed OY

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250318Planmed XFISeptember 26, 2025
K211720Planmed Clarity 2D, Planmed Clarify SJuly 18, 2022
K213278Planmed VerityApril 28, 2022
K192317Planmed Clarity 2D and Clarity SOctober 23, 2020
K180918Planmed VerityNovember 30, 2018
K163328Planmed ClarityDecember 28, 2017
K143435Planmed VerityMay 14, 2015
K121418PLANMED VERITYFebruary 1, 2013
K121963PLANMED NUANCE DIGIGUIDENovember 21, 2012
K042671PLANMED SOPHIE NUANCE CLASSICNovember 19, 2004
K021945PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)February 21, 2003
K013656PLANMED SOPHIE & PLANMED SOPHIE CLASSICJanuary 16, 2002
K010116PLANMED SOPHIE, PLANMED SOPHIE CLASSICMarch 15, 2001
K991826PLANMED SOPHIE AND SOPHIE CLASSICAugust 10, 1999
K983659PLANMED SOPHIE & PLANNED SOPHIE CLASSICNovember 16, 1998
K973493PLANMED CYTOGUIDENovember 10, 1997
K962105PLANNED SOPHIED CLASSICFebruary 5, 1997
K951883PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNITMay 24, 1995
K934373MOBILE SOPHIE MODIFICATIONApril 7, 1994
K923471PLANMED CYTOGUIDENovember 24, 1992