Is this your brand? Sign in to claim ownership.

TYTEK MEDICAL INC

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
HypoFoam	1000	FDA UDI	Class I	Active
Tytek Trauma Bandage	TM-212	FDA UDI	Class I	Active
PneumoDart	TM-317	FDA UDI	Class I	Active
Tpak	TM-310	FDA UDI	Class I	Active
HypoPan	1009	FDA UDI	Class I	Active
Tpak	TM-303	FDA UDI	Class I	Active
Tytek Trauma Bandage	TM-206	FDA UDI	Class I	Active
Surgical HypoHolder	1003	FDA UDI	Class I	Active
Ptensys Bleeding Control Kits	TM-401	FDA UDI	Class I	Active
Ptensys Bleeding Control Station	TM-400	FDA UDI	Class I	Active
Clinical HypoHolder	1004	FDA UDI	Class I	Active
Tytek Trauma Bandage	TM-204	FDA UDI	Class I	Active
Ez Gauze	TM-215	FDA UDI	Class I	Active
Tvac	TM-909	FDA UDI	Class I	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 5, 2020	Z-2611-2023	—	terminated	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Oct 5, 2020	Z-2610-2023	—	terminated	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Oct 5, 2020	Z-2612-2023	—	terminated	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Nov 15, 2019	Z-0930-2020	—	terminated	A defect involving an occluded needle was discovered during a training exercise.