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 Number: 8043728
• FEI Number: 3002807903
• Name: Ed Mcdonough
• Owner & Operator: Planmed Oy
• Contact Address: Asentajankatu 6 ; Helsinki FI-ES Etela-Suomen laani 00880 FI
• Official Correspondent:
  • Lars K Moring
  • 358-20-7795300-x
• US Agent:
  • Ed Mcdonough
  • Planmeca U.S.A. Inc.
  • 630 5292300
  • ed.mcdonough@planmecausa.com
• Importing Logistics Registration:
  • Importer: Planmed Inc.
  • Address: 100 North Gary Avenue, Suite A ; Roselle, IL 60172 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2600 Forbs Ave. ; Hoffman Est, IL 60192 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K213278 Planmed Oy	Planmed Verity	2022-04-28
PMN K192317 Planmed Oy	Planmed Clarity 2D And Clarity S	2020-10-23
PMN K180918 | OAS Ed Mcdonough [Planmed Oy]	Planmed Verity	2019-01-16
PMN K180918 | JAK Ed Mcdonough [Planmed Oy]	Planmed Verity	2019-01-16
GUDID 06430035430079 Planmed Oy	Planmed	2018-12-27
PMN K180918 Planmed Oy	Planmed Verity	2018-11-30
PMN K163328 | MUE Ed Mcdonough [Planmed Oy]	Planmed Clarity	2018-11-20
GUDID 06430035430062 Planmed Oy	Planmed	2018-07-06
GUDID 06430035430055 Planmed Oy	Planmed	2018-07-06
GUDID 06430035430024 Planmed Oy	Planmed	2018-03-29
PMN K163328 Planmed Oy	Planmed Clarity	2017-12-28
PMN K143435 | OAS Ed Mcdonough [Planmed Oy]	Planmed Verity MaxScan	2015-05-19
PMN K143435 | JAK Ed Mcdonough [Planmed Oy]	Planmed Verity MaxScan	2015-05-19
PMN K143435 PLANMED OY	Planmed Verity	2015-05-14
PMN K121418 | JAK Ed Mcdonough [Planmed Oy]	Planmed Verity	2013-04-26
PMN K121418 PLANMED OY	PLANMED VERITY	2013-02-01
PMN K121963 PLANMED OY	PLANMED NUANCE DIGIGUIDE	2012-11-21
PMN K021945 | IZH Ed Mcdonough [Planmed Oy]	Planmed Digiguide	2007-12-05
PMN K013656 | IZH Ed Mcdonough [Planmed Oy]	Planmed Sophie	2007-12-05
PMN K013656 | IZH Ed Mcdonough [Planmed Oy]	Planmed Sophie Classic	2007-12-05
PMN K013656 | IZH Ed Mcdonough [Planmed Oy]	Planmed Sophie Classic S	2007-12-05
PMN K042671 PLANMED OY	PLANMED SOPHIE NUANCE CLASSIC	2004-11-19
PMN K021945 PLANMED OY	PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)	2003-02-21
PMN K013656 PLANMED OY	PLANMED SOPHIE & PLANMED SOPHIE CLASSIC	2002-01-16
PMN K991826 PLANMED OY	PLANMED SOPHIE AND SOPHIE CLASSIC	1999-08-10
PMN K983659 PLANMED OY	PLANMED SOPHIE & PLANNED SOPHIE CLASSIC	1998-11-16
PMN K973493 PLANMED OY	PLANMED CYTOGUIDE	1997-11-10
PMN K962105 PLANMED OY	PLANNED SOPHIED CLASSIC	1997-02-05
PMN K951883 PLANMED OY	PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT	1995-05-24
PMN K934373 PLANMED OY	MOBILE SOPHIE MODIFICATION	1994-04-07
PMN K923471 PLANMED OY	PLANMED CYTOGUIDE	1992-11-24