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FDA 510(k) Applications Submitted by PLANMED OY
FDA 510(k) Number
Submission Date
Device Name
Applicant
K010116
01/16/2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
PLANMED OY
K991826
05/28/1999
PLANMED SOPHIE AND SOPHIE CLASSIC
PLANMED OY
K021945
06/13/2002
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
PLANMED OY
K973493
09/15/1997
PLANMED CYTOGUIDE
PLANMED OY
K042671
09/29/2004
PLANMED SOPHIE NUANCE CLASSIC
PLANMED OY
K013656
11/06/2001
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
PLANMED OY
K180918
04/09/2018
Planmed Verity
Planmed Oy
K121418
05/11/2012
PLANMED VERITY
PLANMED OY
K962105
05/31/1996
PLANNED SOPHIED CLASSIC
PLANMED OY
K121963
07/05/2012
PLANMED NUANCE DIGIGUIDE
PLANMED OY
K192317
08/26/2019
Planmed Clarity 2D and Clarity S
Planmed Oy
K983659
10/19/1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
PLANMED OY
K163328
11/28/2016
Planmed Clarity
Planmed Oy
K143435
12/01/2014
Planmed Verity
PLANMED OY
K211720
06/04/2021
Planmed Clarity 2D, Planmed Clarify S
Planmed Oy
K213278
10/01/2021
Planmed Verity
Planmed Oy
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