Medegen Medical Manufacturing Services: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medegen Medical Manufacturing Services” (first 2004, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| FMF | Syringe, Piston | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Medegen Medical Manufacturing Services 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083765 | MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL | FPA | 2008-12-30 | 12 |
| K052330 | TRU-SWAB STOCOCK | FMG | 2005-09-09 | 14 |
| K051930 | DRUG ACCESS SPIKE | FMF | 2005-08-16 | 34 |
| K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | FPA | 2005-06-22 | 15 |
| K041179 | MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR | FPA | 2004-06-04 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Medegen Medical Manufacturing Services.
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.
- Medegen Medical Manufacturing System (2 510(k)s)
- Medegen, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medegen Medical Manufacturing Services?
FDA lists 5 510(k) clearances under the applicant name “Medegen Medical Manufacturing Services” (first 2004, latest 2008), across 3 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 Medegen Medical Manufacturing Services?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medegen Medical Manufacturing Services is 15 days.
Which FDA product codes appear under Medegen Medical Manufacturing Services?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); FMF (Syringe, Piston, 1); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 5 Medegen Medical Manufacturing Services clearances with predicates and recalls
- Run predicate analysis for product code FPA, Medegen Medical Manufacturing Services'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.