Silimed, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Silimed, LLC” (first 1998, latest 2005), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 70 days. 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 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | 4 | 4 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| KXP | Stent, Vaginal | 1 | 1 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
Review panels
Most recent Silimed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042054 | SILIMED PECTORAL IMPLANT | MIB | 2005-02-23 | 208 |
| K981852 | SILIMED TISSUE EXPANDER | LCJ | 1998-08-05 | 71 |
| K974479 | SILIMED VAGINAL STENT | KXP | 1998-08-05 | 252 |
| K981851 | SILIMED SILICONE CARVING BLOCK | MIB | 1998-07-09 | 44 |
| K981850 | SILIMED CHIN IMPLANTS | FWP | 1998-07-09 | 44 |
| K981835 | SILIMED MALAR IMPLANT | LZK | 1998-07-09 | 44 |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | FZE | 1998-06-26 | 31 |
| K980221 | SILIMED NASAL RETAINER | LYA | 1998-04-02 | 70 |
| K974482 | SILIMED GLUTEAL IMPLANT | MIB | 1998-02-24 | 90 |
| K974480 | SILIMED CALF IMPLANT | MIB | 1998-02-24 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Silimed, LLC.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Silimed, LLC?
FDA lists 10 510(k) clearances under the applicant name “Silimed, LLC” (first 1998, latest 2005), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Silimed, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Silimed, LLC is 70 days.
Which FDA product codes appear under Silimed, LLC?
The most frequent FDA product codes under this applicant name are MIB (Elastomer, Silicone Block, 4); FWP (Prosthesis, Chin, Internal, 1); FZE (Prosthesis, Nose, Internal, 1).
Next steps
- See all 10 Silimed, LLC clearances with predicates and recalls
- Run predicate analysis for product code MIB, Silimed, LLC'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.