Advanced Medical Solutions Limited: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Advanced Medical Solutions Limited” (first 2006, latest 2023), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 336 days, against 233 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 444 |
| 2021 | 0 | — |
| 2022 | 1 | 336 |
| 2023 | 1 | 159 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Advanced Medical Solutions Limited took a median 336 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 233 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 9 | 9 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 | 1 |
| OMD | Cutaneous Tissue Adhesive With Mesh | 1 | 1 |
| PLJ | Tissue Adhesive Internal Use | 1 | 0 |
Review panels
Most recent Advanced Medical Solutions Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | FRO | 2023-04-05 | 159 |
| K211878 | LiquiBand XL | OMD | 2022-05-23 | 336 |
| K183570 | LiquiBand Plus | MPN | 2020-03-09 | 444 |
| K110458 | SILVER ANTIMICROBIAL WOUND GEL | FRO | 2011-03-14 | 25 |
| K091013 | SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND | FRO | 2009-07-30 | 112 |
| K090453 | SILVER ALGINATE 11 WOUND DRESSING | FRO | 2009-02-26 | 3 |
| K080503 | SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING | FRO | 2008-11-12 | 261 |
| K081363 | NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING | FRO | 2008-09-24 | 132 |
| K073197 | SILVER ANTIMICROBIAL WOUND GEL | FRO | 2008-08-28 | 289 |
| K070581 | SILVER ALGINATE II WOUND DRESSING | FRO | 2007-07-13 | 134 |
1 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220024 | PMA | LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device | 2023-06-02 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Medical Solutions Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Medical Solutions Limited?
FDA lists 11 510(k) clearances under the applicant name “Advanced Medical Solutions Limited” (first 2006, latest 2023), plus 1 PMA decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Medical Solutions Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Medical Solutions Limited is 134 days. Since 2017: 336 days, versus 233 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Advanced Medical Solutions Limited?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 9); MPN (Tissue Adhesive For The Topical Approximation Of Skin, 1); OMD (Cutaneous Tissue Adhesive With Mesh, 1).
Next steps
- See all 11 Advanced Medical Solutions Limited clearances with predicates and recalls
- Run predicate analysis for product code FRO, Advanced Medical Solutions Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.