Germiphene Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Germiphene Corp.” (first 1989, latest 1998), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 141 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | 2 | 2 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 | 2 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- Dental (4)
- General Hospital (1)
Most recent Germiphene Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983847 | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT | EIA | 1998-12-01 | 32 |
| K961289 | VAPOPHENE | MED | 1997-12-04 | 609 |
| K964796 | ODYSSEY I DENTAL WATER UNIT | EIA | 1997-05-14 | 166 |
| K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | EJR | 1994-11-04 | 141 |
| K894933 | PERLIDENT | EJR | 1989-10-12 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Germiphene 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 Germiphene Corp.?
FDA lists 5 510(k) clearances under the applicant name “Germiphene Corp.” (first 1989, latest 1998), across 3 product codes in 2 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 Germiphene Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Germiphene Corp. is 141 days.
Which FDA product codes appear under Germiphene Corp.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 2); EJR (Agent, Polishing, Abrasive, Oral Cavity, 2); MED (Sterilant, Medical Devices, 1).
Next steps
- See all 5 Germiphene Corp. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Germiphene 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.