Sivantos G M B H

FDA Filings

This page includes the latest FDA filings for Sivantos G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005019184
• FEI Number: 3005019184
• Name: Sivantos GmbH
• Owner & Operator: Sivantos, Inc.
• Contact Address: 10 Constitution Avenue ; Piscataway NJ 08854 US
• Official Correspondent:
  • Robert Martin
  • 1-732-5626665-x
• US Agent:
  • Jon Schirado
  • Sivantos, Inc.
  • 763 4774677
  • jon.schirado@sivantos.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Henri-Dunant-Str. 100 ; Erlangen Bayern, 91058 DE
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Silk	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Pure	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Pure 13 BT	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Motion	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Intuis	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Insio	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Cellion	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Carat	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Signia Siemens CROS Pure	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Siemens Sirion	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Siemens Orion	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Siemens Nitro	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Siemens Motion	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Siemens Intuis	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Voyage	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Trax	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Sterling	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Stellar	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Quintra	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Onyx	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Motif	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Mosaic	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Legato	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Joy	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Inox	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Finesse	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Emerald	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton CROS	2011-07-12
OSM Sivantos GmbH [Sivantos, Inc.]	Rexton Accord	2011-07-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Silk	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Pure	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Pure 13 BT	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Motion	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Intuis	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Insio	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Cellion	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Carat	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Signia Siemens CROS Pure	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Siemens Sirion	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Siemens Orion	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Siemens Nitro	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Siemens Motion	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Siemens Intuis	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Voyage	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Trax	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Sterling	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Stellar	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Quintra	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Onyx	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Motif	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Mosaic	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Legato	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Joy	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Inox	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Finesse	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Emerald	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton CROS	2010-04-12
PMN K011366 | KLW Sivantos GmbH [Sivantos, Inc.]	Rexton Accord	2010-04-12
PMN K071462 | ETW Sivantos GmbH [Sivantos, Inc.]	Siemens Unity 3 probe (REM)	2010-03-23
PMN K071462 | ETW Sivantos GmbH [Sivantos, Inc.]	Siemens Unity 3 hearing instrument analyzer	2010-03-23
PMN K071462 | ETW Sivantos GmbH [Sivantos, Inc.]	Siemens Unity 2 probe (REM)	2010-03-23
PMN K071462 | ETW Sivantos GmbH [Sivantos, Inc.]	Siemens Unity 2 hearing instrument analyser	2010-03-23
EWO Sivantos GmbH [Sivantos, Inc.]	Siemens Unity 3 Audiometer	2010-01-29
EWO Sivantos GmbH [Sivantos, Inc.]	Siemens Unity 2	2010-01-29
EWO Sivantos GmbH [Sivantos, Inc.]	Siemens HearCheck Screener	2010-01-29
ESD Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Silk	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Intuis	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Insio	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Signia Siemens Ace	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Siemens Sirion	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Siemens Orion	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Siemens Nitro	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Siemens Motion	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Siemens Intuis	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Voyage	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Trax	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Targa	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Strata	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Sterling	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Stellar	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Motif	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Mosaic	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Legato	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Joy	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton InoX	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Fusion PP+	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Finesse	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Emerald	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Arena	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Rexton Accord	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Electone Tango	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Electone Tango Pro	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Electone Sonoro	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Electone Rio	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Electone Rio Sierra	2007-11-28
ESD Sivantos GmbH [Sivantos, Inc.]	Electone Figaro	2007-11-28