Swissray Medical Ag

FDA Filings

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

FDA Registration(s)
Registration Number9614430
FEI Number3002143662
NameSWISSRAY Medical, AG
Owner & OperatorSwissray International, Inc.
Contact Address1090 King Georges Post Road Unit 1203
Edison NJ 08837 US
Official Correspondent
  • Deniz K Kortan
  • 01-908-3726408-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressTURBISTRASSE 25-27
HOCHDORF Luzern, CH 6280 CH
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Swissray Medical AG
ddR Formula Plus 2024-04-24
Swissray Medical AG
ddR Element 2024-04-24
Swissray Medical AG
ddR Cruze 2024-04-24
SWISSRAY Medical, AG [Swissray International, Inc.]
SR Pulse 7102017-04-21
SWISSRAY Medical, AG [Swissray International, Inc.]
ddrAura (TM) Series2016-04-07
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze Plus2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze Plus2013-07-02
SWISSRAY MEDICAL AG
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)2013-06-25
SWISSRAY MEDICAL AG
DDRVERSA MOTION2012-12-07
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRElement2012-10-22
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRElement2012-10-22
SWISSRAY MEDICAL AG
DDRELEMENT2011-08-23
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCompact2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCompact Plus2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCompact Chest2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRFormula2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRFormula Plus2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCombi Trauma2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCombi Plus2008-03-25
SWISSRAY MEDICAL AG
DDRFORMULA AND DDRFORMULA PLUS2005-12-15

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