FDA Registration
Active
🇺🇸 United States
BIONIX, LLC
Reg #: 1526854
·
FEI: 1526854
·
Expires 2026
Products
17
Proprietary Names
29
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- BIONIX, LLC
- Registration Number
- 1526854
- FEI Number
- 1526854
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1670 Indianwood Circle
- City
- Maumee
- State
- OH
- ZIP
- 43537
- Country
- US
Regulatory Submissions
- 510(k) Number
- K905164
Owner / Operator
- Firm Name
- BIONIX, LLC
- Operator Number
- 1526854
- Address
- 1670 Indian Wood Circle, --
- City
- Maumee
- State
- OH
- Postal Code
- 43537
- Country
- US
- Correspondent
- Joshua A Ball
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2008-05-02 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2016-04-11 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2012-02-03 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2010-11-11 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-09-29 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1997-01-10 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2009-09-04 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2000-06-13 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2012-04-10 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2009-06-30 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1997-01-10 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-01-07 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-04-17 |
| Applicator, Ent Drug | LRD | Class 1 | Ear, Nose, Throat | No | 2000-06-13 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2009-09-11 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 1997-01-10 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2026-02-26 |
Proprietary Names
DeClogger
TruGuard
Shotblocker
Ear Irrigation Basin
SecureVac Systems
SecureFoam System
Pelvis Belly System
T-Form SecureVac Box Adaptor
Cerumen Suction Device
Lighted Microsuction System
BIONIX DISPOSABLE NASAL SPECULUM
After Swim
BIONIX OTOCLEAR SAFE IRRIGATION TIP
Safe Straw
Safe Ear Curettes
ClearLook Lighted Ear Curettes
Lighted Ear Curettes
Lighted Placement
IGLOO WOUND IRRIGATOR
SutureOut
BIONIX OTOCLEAR SAFE IRRIGATION
OtoClear Single-Use SprayWash Kit
OtoClear Aquabot
OtoClear SprayWash
OtoClear Spray Wash OTC
Lighted Forceps
Rechargeable Light Source
Original Light Source
Lighted Magnetic Foreign Body Removal Tool
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device