ABL Manufacturing, LLC

FDA Device Registration & Listing · American Fork, UT, US · Registration 3008396914

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008396914
FEI Number
3008396914
Entity Name
ABL Manufacturing, LLC
City/State/Country
American Fork, UT, US
Establishment Address
1306 South 630 East, American Fork, UT 84003, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ABL Manufacturing, LLC (Owner Number: 10033426)
Owner / Operator Contact Address
ABL Manufacturing, LLC, 1306 south 630 east, Am Fork, UT 84003, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SILVRSTAT NANO SILVER WOUND WASH CVS HEALTH NANO SILVER WOUND WASH Silovance Curavance Silvano Wound Wash CareSTAT Wound Dressing Gel SILVRSTAT® Antibacterial Wound Dressing Gel Dermasyn/AG Wound Dressing Gel Silver SG Wound Dressing Gel Silovance Curavance Antibacterial Wound Dressing Gel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-08-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2014-08-06
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-12-15

Official Correspondent

Nathan Moeller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABL Manufacturing, 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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008396914. Last updated year: 2026. Please use registration number 3008396914 when referencing this establishment in official correspondence.
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