Data / Medical devices / United States / Omt, LLC
Omt, LLC: FDA-registered device maker in Fort Lauderdale, FL, United States, 1 510(k) clearance
Omt, LLC is registered with the FDA (registration 3005663073) in Fort Lauderdale, FL, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 3, 2002. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005663073
- Address
- 3848 SW 30th Ave, Fort Lauderdale, FL, United States, 33312
- Owner or operator
- OMT, LLC (9085200)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 31, 2006
- Registered through
- 2027
- Brand names listed
- Cranial Dissectors - Microsurgical, Instruments General, Kerrisons, Pattie / Neuropatties, Pattie Tray, STERICYL's, Silicon Brain Spatulas
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gauze/Sponge, Internal | EFQ | U | Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Specification developer | accessdata.fda.gov |
| Neurosurgical Paddie | HBA | 2 | Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Specification developer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 3, 2002 | K020736 | TRAATEK COTTONOID PATTIES | HBA | Substantially Equivalent | Traatek, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Rongeur
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Neurosurgical Paddie
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Gauze/Sponge, Internal
- All makers of Spatula, Surgical, General & Plastic Surgery
Updated June 3, 2002. 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.