510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Alliance Tech Medical, Inc

Granbury, TX, US

ALLIANCE TECH MEDICAL, INC. appears in FDA device records in Granbury, TX. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Alliance Tech Medical, Inc in 2004.

Clearances by year, as a table
510(k) clearance decisions for Alliance Tech Medical, Inc, by decision year
YearClearances
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K043148ALL FLOW PULMONARY FUNCTION FILTERCAHSubstantially Equivalent

Registered establishments

FDA registered establishments for Alliance Tech Medical, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30044766313004476631ALLIANCE TECH MEDICAL, INC.4053 Acton Highway Suite 103, Granbury, TX 76049 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0714-2020Alliance 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 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.Patients have experienced a bad taste associated with the filters.Class IICompleted

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Alliance Tech Medical, Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain