Colleen Powell

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006073153
• FEI Number: 3006073153
• Name: Colleen Powell
• Owner & Operator: SPECTRUM MEDICAL LTD
• Contact Address: HARRIER 4,METEOR BUSINESS PARK CHELTENHAM ROAD EAST; GLOUCESTER, GLOUCESTERHSIRE GB-NOTA GL2 9QL GB
• Official Correspondent:
  • Colleen M Powell
  • 44-124-2387082-x
• US Agent:
  • Colleen Powell
  • Spectrum Medical Inc.
  • 800 2652331
  • colleen.powell@spectrummedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 481 Munn Road, Suite 180 ; Fort Mills, SC 29715 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 0
• FEI Number: 0
• Name: Colleen Powell
• Owner & Operator: Qura S.r.l.
• Official Correspondent:
  • Raffaella Tommasini
  • 39-535-1803050-x
• US Agent:
  • Colleen Powell
  • Spectrum Medical Inc.
  • 800 2652331
  • colleen.powell@spectrummedical.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 481 Munn Road, Suite 180 ; Fort Mills, SC 29715 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K192850 | KFM Colleen Powell [Qura S.r.l.]	Quantum PureFlow Centrifugal Blood Pump	2020-04-16
PMN K192850 | KFM Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Centrifugal Drive	2020-04-14
PMN K190282 | DTQ Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Smart Occluder	2019-05-28
PMN K181942 | DTX Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Ventilation Module	2018-10-19
PMN K181923 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Workstation 12.1"	2018-08-20
PMN K173834 | DTQ Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Pump Console	2018-05-29
PMN K173591 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Diagnostic Module	2018-03-29
PMN K163657 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	Quantum Workstation	2017-01-23
PMN K110957 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	M4	2011-11-15
OUG Colleen Powell [SPECTRUM MEDICAL LTD]	VIPER	2011-04-04
PMN K091908 | KRL Colleen Powell [SPECTRUM MEDICAL LTD]	M3 Monitor	2009-11-11
PMN K091908 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	M3 Monitor	2009-11-11
PMN K072131 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	SPECTRUM M3 MONITOR	2006-10-30
PMN K071725 | DRY Colleen Powell [SPECTRUM MEDICAL LTD]	SPECTRUM M2 MONITOR	2006-10-30

Similar & Related FDA Registered Companies

• Spectrum Medical Inc.