Spectrum Dynamics Medical Inc

FDA Filings

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

Spectrum Dynamics Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3008007310
FEI Number3008007310
NameSpectrum Dynamics Medical Inc.
Owner & OperatorSpectrum Dynamics Medical, Inc.
Contact Address301 N. Cattlemen Rd. Suite 109
Sarasota FL 34232 US
Official Correspondent
  • Jim Haisler
  • 001-941-2563660-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address301 N. Cattlemen Rd. Suite 109
Sarasota, FL 34232 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
SPECTRUM DYNAMICS MEDICAL, INC
VERITON NM 8010427-012023-06-09
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 8010419-012023-06-09
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 8010420-012023-06-09
SPECTRUM DYNAMICS MEDICAL, INC
VERITON NM 8010426-012023-06-09
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 8010422-012023-06-09
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 8010421-012023-06-09
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT Refurbished 8010013-012020-12-21
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT VISTA 8010267-012020-10-01
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT Refurbished 8010013-012020-09-03
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT VISTA 8010266-012020-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT VISTA 8010267-012020-07-06
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 8010172-012020-07-01
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 8010142-012019-01-11
SPECTRUM DYNAMICS MEDICAL, INC
VERITON NM 8010184-012018-12-10
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
VERITON CT2018-11-18
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
VERITON CT2018-11-18
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
VERITON NM2018-07-26
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT ® processing and Reviewing Workstation 8010113-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® Cardio 8010121-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® Cardio 8010120-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® L 8010032-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® L 8010020-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® 8010018-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® 8010018-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® 8010029-012018-07-06
SPECTRUM DYNAMICS MEDICAL, INC
D-SPECT® 8010029-012018-07-06
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
D-SPECT CARDIO2017-10-26
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
D-SPECT Standalone Processing Station2016-10-30
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
D-SPECT Standalone Processing Station2016-10-30
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
D-Spect2013-06-27
Spectrum Dynamics Medical Inc. [Spectrum Dynamics Medical, Inc.]
D-Spect L2013-06-27

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