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Advanced Medical Solutions Ltd: FDA-registered device maker in WINSFORD Cheshire East, United Kingdom, 13 510(k) clearances

Name: Advanced Medical Solutions Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Advanced Medical Solutions Ltd is registered with the FDA (registration 8044178) in WINSFORD Cheshire East, United Kingdom. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 26, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8044178
FEI number: 3003080333
Address: Premier Park, 33 Road One WINSFORD INDUSTRIAL ESTATE, WINSFORD Cheshire East, United Kingdom, CW7 3RT
Owner or operator: ADVANCED MEDICAL SOLUTIONS GROUP PLC (9031453)
Roles: Contract manufacturer, Manufacturer
First device listed: June 13, 2001
Registered through: 2026
Brand names listed: 3M SILVERCEL® Hydro-Alginate Antimicrobial Dressing with Silver, 3M SILVERCEL® Nonadherent Hydro-Alginate Antimicrobial Dressing, ACTIVHEAL® Aquafiber Extra Ag, ACTIVHEAL® Moisture Wicking Fabric Ag, ACTIVHEAL® PHMB FOAM SILICONE ADHESIVE BORDER, ACTIVHEAL® SILVER FIBER Ag, ActivHeal Aquafiber® Extra Ag, ActivHeal® Actibride and more

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Wound, Drug	FRO	U	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 26, 2023	K213473	Antimicrobial Gelling Fiber Dressing with PHMB	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov
April 5, 2023	K223310	Antimicrobial Silicone PHMB Foam Wound Dressing	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
May 12, 2021	K210974	High Performance Antimicrobial Gelling Fiber with Silver	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov
July 25, 2019	K190819	Silicone PHMB Foam Wound Dressing	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov
May 29, 2019	K183645	Silver High Performance Dressing	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov
August 7, 2018	K180634	Surgical Silver Post Operative Dressing	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov
August 3, 2018	K181197	PHMB Foam Wound Dressing	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov
March 14, 2011	K110458	SILVER ANTIMICROBIAL WOUND GEL	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
February 26, 2009	K090453	SILVER ALGINATE 11 WOUND DRESSING	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
November 12, 2008	K080503	SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
September 24, 2008	K081363	NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
July 13, 2007	K070581	SILVER ALGINATE II WOUND DRESSING	FRO	Substantially Equivalent	Advanced Medical Solutions Limited	accessdata.fda.gov
June 30, 2003	K024298	ANTIMICROBIAL ALGINATE DRESSING	FRO	Substantially Equivalent	Advanced Medical Solutions, Ltd.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
October 1, 2024	95613	Class II	Ongoing	Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: pressure ulcers leg ulcers cavity wounds lacerations po	Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.	accessdata.fda.gov
January 15, 2015	75033	Class II	Terminated	ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton cont	On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse	accessdata.fda.gov

Compare with other makers

Updated December 4, 2024. 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.