Data / Medical devices / United States / Directmed, Inc.
Directmed, Inc.: FDA-registered device maker in Glen Cove, NY, United States, 1 510(k) clearance
Directmed, Inc. is registered with the FDA (registration 2437459) in Glen Cove, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2437459
- FEI number
- 3000718659
- Address
- 98 Pratt Oval, Glen Cove, NY, United States, 11542
- Owner or operator
- DIRECTMED, INC. (9030198)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 8, 2021
- Registered through
- 2026
- Brand names listed
- Curaplex, DIRECTMED, Fresenius Kabi USA, LLC, Grace Medical, Inc., HMG Distribution LLC, MARIAN MEDICAL, Medaxis LLC, Medical Marketing, Inc. and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Complaint file establishment | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2015 | K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension Set | FPA | Substantially Equivalent | Imed Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 28, 2015. 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.