Tytek Medical Inc
West Chester, OH, US
TYTEK MEDICAL INC appears in FDA device records in West Chester, OH. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004551550 | 3004551550 | TYTEK MEDICAL INC | 8904 Beckett Rd., West Chester, OH 45069 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- BSYCatheters, Suction, Tracheobronchial
- OHOFirst Aid Kit Without Drug
- NABGauze / Sponge,Nonresorbable For External Use
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- GAANeedle, Aspiration And Injection, Disposable
- MRIOrthosis, Truncal/Orthosis, Limb
- JOKScissors, Medical, Disposable
- FPPStretcher, Hand-Carried
- GAXTourniquet, Nonpneumatic
- LRPTray, Surgical
- JOHTube Tracheostomy And Tube Cuff
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2612-2023 | TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317 | Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location | Class II | Terminated | |
| Z-2611-2023 | TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310 | Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location | Class II | Terminated | |
| Z-2610-2023 | TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303 | Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location | Class II | Terminated | |
| Z-0930-2020 | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition. | A defect involving an occluded needle was discovered during a training exercise. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain