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Allwell Medical Corporation: FDA-registered device maker in Raleigh, NC, United States, 9 510(k) clearances

Name: Allwell Medical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Allwell Medical Corporation is registered with the FDA (registration 3007138831) in Raleigh, NC, United States. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 16, 2014. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007138831
Address: 7424 Chapel Hill Rd 204, Raleigh, NC, United States, 27607
Owner or operator: Allwell Medical Corporation (10024817)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: February 26, 2008
Registered through: 2026
Brand names listed: Allwell Nastrogastric Feeding Tube, Angioplasty Pack, Coronary Control Syringe, Homostasis Valve, Inflation Device, Inflation Syringe Kit, Introducer (Guide Wire Insertion To, Manifolds and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Angiography/Angioplasty Kit	OEQ	2	Manufacturer for export	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Repackager or relabeler	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Tube, Feeding	FPD	2	Repackager or relabeler	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 16, 2014	K141753	AQUARIUS NASAL FEEDING TUBE	PIF	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
December 19, 2012	K122321	BASIXCONPAK ANALOG INFLATION SYRINGE	MAV	Substantially Equivalent	Merit Medical Ireland, Ltd.	accessdata.fda.gov
March 15, 1994	K936032	TORQUE DEVICE	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 22, 1993	K925419	PASSAGE HEMOSTASIS VALVE	DTL	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
December 11, 1992	K915301	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	DTL	Substantially Equivalent	Advance Medical Designs, Inc.	accessdata.fda.gov
September 21, 1992	K921702	MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 16, 1991	K911732	ADVANCE DISPOSABLE CONTROL SYRINGE	IZI	Substantially Equivalent	Advance Medical Designs, Inc.	accessdata.fda.gov
April 18, 1989	K884913	MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)	DXT	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 10, 1978	K781558	PRESSURE MONITORING INJECTION LINES	DQO	Substantially Equivalent	Cobe Laboratories, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 16, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.