Seare Biomedical Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Seare Biomedical Corp.” (first 1998, latest 1998), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 55 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 | 2 | 2 |
| MIC | Implant, Muscle, Pectoralis | 2 | 2 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
Review panels
Most recent Seare Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983792 | SEARE BIOMEDICAL SILICONE TISSUE EXPANDER | LCJ | 1998-12-11 | 45 |
| K983630 | SEARE BIOMEDICAL SILICONE RODS | MIB | 1998-12-11 | 57 |
| K983043 | SEARE BIOMEDICAL SILICONE BLOCK | MIC | 1998-09-30 | 30 |
| K983041 | SEARE BIOMEDICAL SILICONE SHEETING | MIB | 1998-09-30 | 30 |
| K982763 | SEARE BIOMEDICAL MALAR IMPLANTS | LZK | 1998-09-30 | 55 |
| K982762 | SEARE BIOMEDICAL PECTORALIS IMPLANT | MIC | 1998-09-30 | 55 |
| K982753 | SEARE BIOMEDICAL NASAL IMPLANTS | FZE | 1998-09-30 | 55 |
| K982752 | SEARE BIOMEDICAL CHIN IMPLANTS | FWP | 1998-09-30 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Seare Biomedical Corp..
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 Seare Biomedical Corp.?
FDA lists 8 510(k) clearances under the applicant name “Seare Biomedical Corp.” (first 1998, latest 1998), across 6 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 Seare Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seare Biomedical Corp. is 55 days.
Which FDA product codes appear under Seare Biomedical Corp.?
The most frequent FDA product codes under this applicant name are MIB (Elastomer, Silicone Block, 2); MIC (Implant, Muscle, Pectoralis, 2); FWP (Prosthesis, Chin, Internal, 1).
Next steps
- See all 8 Seare Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code MIB, Seare Biomedical Corp.'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.