Planmed Oy

FDA Filings

This page includes the latest FDA filings for Planmed Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8043728
FEI Number3002807903
NameEd Mcdonough
Owner & OperatorPlanmed Oy
Contact AddressAsentajankatu 6
Helsinki FI-ES Etela-Suomen laani 00880 FI
Official Correspondent
  • Lars K Moring
  • 358-20-7795300-x
US Agent
Importing Logistics Registration
ImporterPlanmed Inc.
Address100 North Gary Avenue, Suite A
Roselle, IL 60172 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2600 Forbs Ave.
Hoffman Est, IL 60192 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Planmed Oy
Planmed Clarity 2D And Clarity S2020-10-23
Ed Mcdonough [Planmed Oy]
Planmed Verity2019-01-16
Ed Mcdonough [Planmed Oy]
Planmed Verity2019-01-16
Planmed Oy
Planmed 2018-12-27
Planmed Oy
Planmed Verity2018-11-30
Ed Mcdonough [Planmed Oy]
Planmed Clarity2018-11-20
Planmed Oy
Planmed 2018-07-06
Planmed Oy
Planmed 2018-07-06
Planmed Oy
Planmed 2018-03-29
Planmed Oy
Planmed Clarity2017-12-28
Ed Mcdonough [Planmed Oy]
Planmed Verity MaxScan2015-05-19
Ed Mcdonough [Planmed Oy]
Planmed Verity MaxScan2015-05-19
PLANMED OY
Planmed Verity2015-05-14
Ed Mcdonough [Planmed Oy]
Planmed Verity2013-04-26
PLANMED OY
PLANMED VERITY2013-02-01
PLANMED OY
PLANMED NUANCE DIGIGUIDE2012-11-21
Ed Mcdonough [Planmed Oy]
Planmed Digiguide2007-12-05
Ed Mcdonough [Planmed Oy]
Planmed Sophie2007-12-05
Ed Mcdonough [Planmed Oy]
Planmed Sophie Classic2007-12-05
Ed Mcdonough [Planmed Oy]
Planmed Sophie Classic S2007-12-05
PLANMED OY
PLANMED SOPHIE NUANCE CLASSIC2004-11-19
PLANMED OY
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)2003-02-21
PLANMED OY
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC2002-01-16
PLANMED OY
PLANMED SOPHIE AND SOPHIE CLASSIC1999-08-10
PLANMED OY
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC1998-11-16
PLANMED OY
PLANMED CYTOGUIDE1997-11-10
PLANMED OY
PLANNED SOPHIED CLASSIC1997-02-05
PLANMED OY
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT1995-05-24
PLANMED OY
MOBILE SOPHIE MODIFICATION1994-04-07
PLANMED OY
PLANMED CYTOGUIDE1992-11-24

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