Data / Medical devices / Applicator, Ent Drug
Applicator, Ent Drug (LRD): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Applicator, Ent Drug (product code LRD, Class 1, 21 CFR 874.5220). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 19, 1999, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LRD
- Device class
- 1
- Regulation
- 874.5220
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| India | 2 |
| Pakistan | 1 |
| United Kingdom | 1 |
| China | 1 |
Makers of Applicator, Ent Drug
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | April 26, 1993 | 0 | 0 | 0 | api.fda.gov |
| Bionix, LLC | Maumee, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blue Echo Care | Portland, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diligent Medical Services | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTR Medical Ltd | Swansea, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omega Plastics, Inc. | Clinton Township, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 19, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.