Advanced Medical Solutions Limited
WINSFORD Cheshire East, GB
Advanced Medical Solutions Limited appears in FDA device records in WINSFORD Cheshire East, GB. FDA records list 22 510(k) clearances between and , 4 PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Advanced Medical Solutions Limited between 2001 and 2023. The busiest year on record is 2008, with 3. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2011 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | FRO | Substantially Equivalent | |
| K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | FRO | Substantially Equivalent | |
| K211878 | LiquiBand XL | OMD | Substantially Equivalent | |
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | FRO | Substantially Equivalent | |
| K183570 | LiquiBand Plus | MPN | Substantially Equivalent | |
| K190819 | Silicone PHMB Foam Wound Dressing | FRO | Substantially Equivalent | |
| K183645 | Silver High Performance Dressing | FRO | Substantially Equivalent | |
| K180634 | Surgical Silver Post Operative Dressing | FRO | Substantially Equivalent | |
| K181197 | PHMB Foam Wound Dressing | FRO | Substantially Equivalent | |
| K163062 | PHMB Antimicrobial Foam Wound Dressing | FRO | Substantially Equivalent | |
| K110458 | SILVER ANTIMICROBIAL WOUND GEL | FRO | Substantially Equivalent | |
| K091013 | SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND | FRO | Substantially Equivalent | |
| K090453 | SILVER ALGINATE 11 WOUND DRESSING | FRO | Substantially Equivalent | |
| K080503 | SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING | FRO | Substantially Equivalent | |
| K081363 | NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING | FRO | Substantially Equivalent | |
| K073197 | SILVER ANTIMICROBIAL WOUND GEL | FRO | Substantially Equivalent | |
| K070581 | SILVER ALGINATE II WOUND DRESSING | FRO | Substantially Equivalent | |
| K063173 | MODIFICATION TO SILVER ALGINATE II WOUND DRESSING | FRO | Substantially Equivalent | |
| K032742 | SILVER FOAM WOUND DRESSING | FRO | Substantially Equivalent | |
| K041316 | ANTIMICROBIAL ALGINATE DRESSING | FRO | Substantially Equivalent | |
| K024298 | ANTIMICROBIAL ALGINATE DRESSING | FRO | Substantially Equivalent | |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | MDA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617175 | 3010571423 | Advanced Medical Solutions Limited | WESTERN WOOD WAY, PLYMOUTH Devon PL7 5BG GB | 2026 | |
| 8044178 | 3003080333 | Advanced Medical Solutions Ltd | Premier Park, 33 Road One, WINSFORD Cheshire East CW7 3RT GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KMFBandage, Liquid
- OMDCutaneous Tissue Adhesive With Mesh
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- FRLFiber, Medical, Absorbent
- NABGauze / Sponge,Nonresorbable For External Use
- NZPSealant, Microbial
- MPNTissue Adhesive For The Topical Approximation Of Skin
- PLJTissue Adhesive Internal Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0619-2025 | MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. | Class II | Open, Classified | |
| Z-0618-2025 | McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds. | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. | Class II | Open, Classified | |
| Z-0617-2025 | 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 post-operative surgical wounds | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. | Class II | Open, Classified | |
| Z-2720-2016 | ReliaMed 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 contains one (1) Instructions For Use (IFU) leaflet. | 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 | Class II | Terminated | |
| Z-2719-2016 | 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 contains one (1) Instructions For Use (IFU) leaflet. | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain