Allwell Medical Corp

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007138831
• FEI Number: 3007138831
• Name: ALLWELL MEDICAL CORPORATION
• Owner & Operator: Allwell Medical Corporation
• Contact Address: 7424 Chapel Hill Rd 204 ; Raleigh NC 27607 US
• Official Correspondent:
  • Jeff Wang
  • x-919-3456294-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7424 Chapel Hill Rd 204 ; Raleigh, NC 27607 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K141753 | PIF ALLWELL MEDICAL CORPORATION	Allwell Nastrogastric Feeding Tube	2018-09-08
PMN K141753 | FPD ALLWELL MEDICAL CORPORATION	Allwell Nastrogastric Feeding Tube	2018-09-08
PMN K122321 | MAV ALLWELL MEDICAL CORPORATION	Inflation Device	2015-02-23
PMN K936032 | DQX ALLWELL MEDICAL CORPORATION	Torque Device	2010-06-26
PMN K921702 | DQX ALLWELL MEDICAL CORPORATION	Introducer (Guide Wire Insertion To	2010-06-26
PMN K925419 | DTL ALLWELL MEDICAL CORPORATION	Stockcocks	2010-05-29
PMN K925419 | DTL ALLWELL MEDICAL CORPORATION	Homostasis Valve	2010-05-29
PMN K925419 | DTL ALLWELL MEDICAL CORPORATION	Angioplasty Pack	2010-05-29
PMN K884913 | DXT ALLWELL MEDICAL CORPORATION	Inflation Syringe Kit	2010-05-29
PMN K884913 | DXT ALLWELL MEDICAL CORPORATION	Inflation Device	2010-05-29
PMN K915301 | DTL ALLWELL MEDICAL CORPORATION	Manifolds	2009-02-16
PMN K911732 | IZI ALLWELL MEDICAL CORPORATION	Coronary Control Syringe	2009-02-16
PMN K781558 | DQO ALLWELL MEDICAL CORPORATION	Presure Monitoring Tube	2009-02-16