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FDA 510(k) Applications Submitted by BOB PIENKOWSKI
FDA 510(k) Number
Submission Date
Device Name
Applicant
K010116
01/16/2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
PLANMED OY
K000454
02/11/2000
DIMEX 2
PLANMECA OY
K000771
03/09/2000
DIMAX 2
PLANMECA OY
K091197
04/23/2009
PLANMECA PROSENSOR
PLANMECA OY
K111361
05/16/2011
PLANMED NUANCE EXCEL
PLANMECA USA, INC.
K011619
05/25/2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
PLANMECA OY
K991826
05/28/1999
PLANMED SOPHIE AND SOPHIE CLASSIC
PLANMED OY
K051464
06/03/2005
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
PLANMECA OY
K021945
06/13/2002
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
PLANMED OY
K081699
06/17/2008
PLANMECA SOVEREIGN
PLANMECA USA, INC.
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
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