Nexmed, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Nexmed, Inc.” (first 1995, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Nexmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033580 | NEXFLEX TOTAL HIP SYSTEM | LPH | 2004-08-05 | 266 |
| K991882 | NEXFLEX TOTAL KNEE SYSTEM | JWH | 1999-12-08 | 189 |
| K955171 | NEXLOCK FEMORAL STEM | JDG | 1996-02-09 | 88 |
| K955170 | NEXFLEX FEMORAL STEM, STANDARD DESIGN | LPH | 1996-02-09 | 88 |
| K952629 | NEXFLEX TOTAL HIP SYSTEM | JDI | 1995-09-08 | 92 |
| K951656 | NEXMED CANCELLOUS BONE SCREWS | HWC | 1995-07-18 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Nexmed, 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.
- Nexmed Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nexmed, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Nexmed, Inc.” (first 1995, latest 2004), across 5 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 Nexmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nexmed, Inc. is 96 days.
Which FDA product codes appear under Nexmed, Inc.?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2); HWC (Screw, Fixation, Bone, 1); JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal, 1).
Next steps
- See all 6 Nexmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Nexmed, 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.