Amerimed US Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Amerimed US Corp.” (first 1988, latest 1989), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| LBK | Neurosurgical Ultrasonic Instruments | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (4)
- Neurology (1)
Most recent Amerimed US Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891722 | LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO) | LYY | 1989-07-14 | 115 |
| K891437 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-31 | 77 |
| K891436 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-31 | 77 |
| K890967 | VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) | LYZ | 1989-05-04 | 66 |
| K883522 | AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT | LBK | 1988-09-30 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Amerimed US 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.
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.
- Amerimed Systems L.C. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amerimed US Corp.?
FDA lists 5 510(k) clearances under the applicant name “Amerimed US Corp.” (first 1988, latest 1989), 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 Amerimed US Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amerimed US Corp. is 77 days.
Which FDA product codes appear under Amerimed US Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 3); LBK (Neurosurgical Ultrasonic Instruments, 1); LYZ (Vinyl Patient Examination Glove, 1).
Next steps
- See all 5 Amerimed US Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Amerimed US 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.