Advanced Medical Solutions, Ltd.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under 2 spellings of the applicant name “Advanced Medical Solutions, Ltd.” (first 2001, latest 2023), plus 1 PMA decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 141 days. Since 2017 the median was 156 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 | 1 | 265 |
| 2018 | 2 | 118 |
| 2019 | 2 | 134 |
| 2020 | 1 | 444 |
| 2021 | 1 | 41 |
| 2022 | 1 | 336 |
| 2023 | 2 | 444 |
| 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, Ltd. took a median 156 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 | 19 | 19 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
| 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, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | FRO | 2023-10-26 | 728 |
| K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | FRO | 2023-04-05 | 159 |
| K211878 | LiquiBand XL | OMD | 2022-05-23 | 336 |
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | FRO | 2021-05-12 | 41 |
| K183570 | LiquiBand Plus | MPN | 2020-03-09 | 444 |
| K190819 | Silicone PHMB Foam Wound Dressing | FRO | 2019-07-25 | 115 |
| K183645 | Silver High Performance Dressing | FRO | 2019-05-29 | 154 |
| K180634 | Surgical Silver Post Operative Dressing | FRO | 2018-08-07 | 148 |
| K181197 | PHMB Foam Wound Dressing | FRO | 2018-08-03 | 88 |
| K163062 | PHMB Antimicrobial Foam Wound Dressing | FRO | 2017-07-25 | 265 |
12 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
5 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2024-10-01.
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.
Device clinical trials
An industry sponsor named Advanced Medical Solutions, Ltd. is the lead sponsor of 9 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07255937: PMCF Study of Debridement Pad (Recruiting, started 2025-11-20)
- NCT05690685: PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) (Completed, started 2023-05-16)
- NCT04740775: LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures (Completed, started 2022-11-08)
- NCT05045430: PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds (Completed, started 2022-07-13)
- NCT04059640: PMCF Study of LiquiBand FIX8® OHMF Device (Active not recruiting, started 2021-12-07)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Advanced Medical Solutions Limited (12)
- Advanced Medical Solutions, Ltd. (11)
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, Ltd.?
FDA lists 22 510(k) clearances under 2 spellings of the applicant name “Advanced Medical Solutions, Ltd.” (first 2001, latest 2023), plus 1 PMA decision, across 5 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, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Medical Solutions, Ltd. is 141 days. Since 2017: 156 days, versus 233 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Advanced Medical Solutions, Ltd.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 19); MDA (Elastomer, Silicone, For Scar Management, 1); MPN (Tissue Adhesive For The Topical Approximation Of Skin, 1).
Next steps
- See all 22 Advanced Medical Solutions, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Advanced Medical Solutions, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.