FDA.reportPublic FDA data

ALLWELL MEDICAL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071388313007138831ALLWELL MEDICAL CORPORATION1N2026-01-017424 Chapel Hill Rd 204 Raleigh NC US 27607

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
846401962625143K936032TORQUE DEVICEDQX1994-03-15
846401346112603K925419PASSAGE HEMOSTASIS VALVEDTL1993-01-22
846401860905565K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQX1992-09-21
846401692572008K915301ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCKDTL1992-12-11
846401111354172K911732ADVANCE DISPOSABLE CONTROL SYRINGEIZI1991-09-16
846401808564105K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)DXT1989-04-18
846401864905862K781558PRESSURE MONITORING INJECTION LINESDQO1978-10-10
846401929312054K141753AQUARIUS NASAL FEEDING TUBEPIF2014-10-16
846401188492321K122321BASIXCONPAK ANALOG INFLATION SYRINGEMAV2012-12-19
846401136653908

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX21994-03-15
DTL21993-01-22
PIF12014-10-16
MAV12012-12-19
IZI11991-09-16
DXT11989-04-18
DQO11978-10-10