Full Synergy Medical Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Full Synergy Medical Products, Inc.” (first 2012, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 72 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 | 6 | 72 |
| 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Full Synergy Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113749 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR | LYZ | 2012-03-15 | 85 |
| K113790 | DISPOSABLE VINYL EXAM GLOVE, POWDERED | LYZ | 2012-03-06 | 74 |
| K113750 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR | LYZ | 2012-03-05 | 75 |
| K113797 | DISPOSABLE VINYL EXAM GLOVE, POWDER FREE | LYZ | 2012-03-02 | 70 |
| K113722 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR | LYZ | 2012-02-14 | 57 |
| K113710 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR | LYZ | 2012-02-14 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Full Synergy Medical Products, Inc..
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.
- Full Spectrum, Inc. (3 510(k)s)
- Full Golden Biotech Co., Ltd. (2 510(k)s)
- Full Power Aed (1 510(k)s)
- Full See Glasses Ind. Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Full Synergy Medical Products, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Full Synergy Medical Products, Inc.” (first 2012, latest 2012), across 1 product code 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 Full Synergy Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Full Synergy Medical Products, Inc. is 72 days.
Which FDA product codes appear under Full Synergy Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 6).
Next steps
- See all 6 Full Synergy Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Full Synergy Medical Products, Inc.'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.