Data / Medical devices / United States / Bionix, LLC
Bionix, LLC: FDA-registered device maker in Maumee, OH, United States, 1 510(k) clearance
Bionix, LLC is registered with the FDA (registration 1526854) in Maumee, OH, United States. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 1991. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1526854
- Address
- 1670 Indianwood Circle, Maumee, OH, United States, 43537
- Owner or operator
- BIONIX, LLC (1526854)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 10, 1997
- Registered through
- 2026
- Brand names listed
- After Swim, BIONIX DISPOSABLE NASAL SPECULUM, BIONIX OTOCLEAR SAFE IRRIGATION, BIONIX OTOCLEAR SAFE IRRIGATION TIP, Cerumen Suction Device, ClearLook Lighted Ear Curettes, DeClogger, Ear Irrigation Basin and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Ent Drug | LRD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Utensil, Eating | ILC | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 13, 1991 | K905164 | TUBE DECLOGGER | KNT | Substantially Equivalent | Nova Design Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Syringe, Ent
- All makers of Speculum, Ent
- All makers of Forceps, Ent
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Applicator, Ent Drug
Updated February 13, 1991. 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.