FDA Registration
Active
🇺🇸 United States
TYTEK MEDICAL INC
Reg #: 3004551550
·
FEI: 3004551550
·
Expires 2026
Products
13
Proprietary Names
33
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- TYTEK MEDICAL INC
- Registration Number
- 3004551550
- FEI Number
- 3004551550
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8904 Beckett Rd.
- City
- West Chester
- State
- OH
- ZIP
- 45069
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133528
Owner / Operator
- Firm Name
- TyTek Medical Inc
- Operator Number
- 10035776
- Address
- 8904 Beckett Rd.
- City
- West Chester
- State
- OH
- Postal Code
- 45069
- Country
- US
- Correspondent
- Chris C Tyler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-05-08 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2022-11-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2011-03-23 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2011-03-23 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-12-14 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2022-11-07 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2025-06-10 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2025-04-16 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2014-11-10 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2018-09-07 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2011-03-23 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2011-03-23 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2011-06-14 |
Proprietary Names
Surgical HypoHolder
Clinical HypoHolder
TM-512 Xtricate Lyte Individual Stretcher
TM-212 Abdominal Trauma Bandage
TM-206 6" Trauma Bandage
TM-204 4" Trauma Bandage
1010TMS Wolf Trauma Bandage 4"; 1020 TMS Tiger Trauma Bandage 6"; 1030TMS Bear Multi-Wound Bandage
PneumoDart
Tpak
Tapk 10
DART
PDF185 TMT Tourniquet; PDF186 TMT Tourniquet; PDF187 TMT Tourniquet
TM-707 Large Piranha Trauma Shears
TM-705 Small Piranha Trauma Shears
HypoFoam
HypoPan
Crico Tube
Ptensys Bleeding Control Station Enhanced, TM-405
Ptensys Bleeding Control Station, TM-400
Ptensys Bleeding Control Kit, TM-401
Ptensys Bleeding Control Kits Enhanced, TM-406
Ptensys Individual Bleeding Control Kit Ultimate, TM-412
Ptensys Bleeding Control Pouch, TM-403
Ptensys Bleeding Control Station Ultimate, TM-409
Ptensys Bleeding Control Pouch Enhanced, TM-407
Ptensys Bleeding Control Kits Ultimate, TM-410
Ptensys Individual Bleeding Control Kit, TM-404
Ptensys Bleeding Control Pouch Ultimate, TM-411
Ptensys Individual Bleeding Control Kits Enhanced, TM-408
TM-215 EZ Gauze
TM-511 Xtricate Rescue Sleeve
TM-909 TVAC-Manual Suction Device
FP-909 TVAC - Manual Suction Device
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility