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Data / Medical devices / United States / Alliance Tech Medical, Inc.

Alliance Tech Medical, Inc.: FDA-registered device maker in Granbury, TX, United States, 1 510(k) clearance

Alliance Tech Medical, Inc. is registered with the FDA (registration 3004476631) in Granbury, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2004. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3004476631
Address
4053 Acton Highway Suite 103, Granbury, TX, United States, 76049
Owner or operator
ALLIANCE TECH MEDICAL, INC. (9060999)
Roles
Repackager or relabeler, Specification developer
First device listed
November 20, 2007
Registered through
2026
Brand names listed
All FLOW, All FLOW Pulmonary Function Filter, All Flow, InFloCone

Devices it lists

DeviceProduct codeClassRoleSource
Filter, Bacterial, Breathing-CircuitCAH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Mouthpiece, BreathingBYP1Repackager or relabeler, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 13, 2004K043148ALL FLOW PULMONARY FUNCTION FILTERCAHSubstantially EquivalentAlliance Tech Medical, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 6, 201483830Class IICompletedAlliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 ReorPatients have experienced a bad taste associated with the filters.accessdata.fda.gov

Compare with other makers

Updated December 13, 2004. 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.