Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010763707

FEI Number

3010763707

Entity Name

ADVANCED MEDICAL ASSOCIATES, LLC

City/State/Country

Dallas, TX, US

Establishment Address

3824 Cedar Springs Dr, #422, Dallas, TX 75219, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Areza Medical (DBA for Advanced Medical Associates LLC) (Owner Number: 10046301)

Owner / Operator Contact Address

811Farmers Market Way, Dallas, TX 75201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silver Foam with or without Border Fabric Skin Tape (Fabripore) Silver Alginate Dressing Silver Foam with or without Border Calcium Alginate Wound Dressing Ultra-Absorbent Silicone Foam with Adhesive Border Transparent Adhesive Film Foam Dressing with Adhesive Border Island Wound Dressing (Bordered Gauze) Showerproof Transparent Adhesive Film Foam Dressing Sacral Ultra-Absorbent Silicone Foam Border

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-10-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-10-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-10-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-10-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-08-17

Official Correspondent

Alireza Atef

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Areza Medical (DBA for Advanced Medical Associates LLC)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010763707. Last updated year: 2026. Please use registration number 3010763707 when referencing this establishment in official correspondence.