Data / Medical devices / United States / Ceplast Medical Devices, LLC
Ceplast Medical Devices, LLC: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
Ceplast Medical Devices, LLC is registered with the FDA (registration 3006411563) in Miami, FL, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006411563
- Address
- 201 S Biscayne Blvd Ste 1200, Miami, FL, United States, 33131
- Owner or operator
- CEPLAST MEDICAL DEVICES, LLC (9105600)
- Roles
- Complaint file establishment
- First device listed
- December 29, 2021
- Registered through
- 2026
- Brand names listed
- AGACHAMBER SPACER EXTRA, Dalmatian Reflex Hammer, Dispositivo para Lavagem Nasal Pequenos Cuidados, NOSE WASH MAX, Nose Wash Syringe, ROCKET DOSER, TIC - TONG FLAVORED TONGUE DEPRESSOR BIO, TIC -TONG FLAVORED TONGUE DEPRESSOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Depressor, Tongue, Non-Surgical | FMA | 1 | Complaint file establishment | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Complaint file establishment | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Complaint file establishment | accessdata.fda.gov |
| Percussor | GWZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| April 29, 2011 | K101348 | AGACHAMBER SPACER | NVP | Substantially Equivalent | Aga Plastic Ind. Com. Ltda. | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Liquid Medication
- All makers of Syringe, Ent
- All makers of Holding Chambers, Direct Patient Interface
- All makers of Percussor
- All makers of Depressor, Tongue, Non-Surgical
- All makers of Irrigator, Sinus
Updated April 29, 2011. 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.