Data / Medical devices / United States / Ebner Medical LLC
Ebner Medical LLC: FDA-registered device maker in Orange Park, FL, United States, 3 510(k) clearances
Ebner Medical LLC is registered with the FDA (registration 1058020) in Orange Park, FL, United States. It lists 21 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 21, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1058020
- FEI number
- 1000222207
- Address
- 555 Blanding Blvd Ste B, Orange Park, FL, United States, 32073
- Owner or operator
- Ebner Medical LLC (10055312)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- September 16, 2020
- Registered through
- 2027
- Brand names listed
- ACE Medical, ACE Medical Co, Curette, Dissector, Surgical, General & Plastic Surgery, Ebner Medical, Isabella, MedPro, RONGEUR and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 21, 2020 | K200387 | Ace Medical Surgical Instruments | HAE | Substantially Equivalent | Ace Medical | accessdata.fda.gov |
| July 21, 2020 | K200383 | Wiggins Medical Surgical Instruments | HAE | Substantially Equivalent | Wiggins Medical | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Scissors, Orthopedic, Surgical
- All makers of Curette
- All makers of Holder, Needle; Orthopedic
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Orthopedic Manual Surgical Instrument
Updated July 21, 2020. 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.