Tytek Medical Inc

FDA Filings

This page includes the latest FDA filings for Tytek Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004551550
• FEI Number: 3004551550
• Name: TYTEK MEDICAL INC
• Owner & Operator: TyTek Medical Inc
• Contact Address: 4700 Ashwood Dr., Ste 445 ; Cincinnati OH 45241 US
• Official Correspondent:
  • Chris C Tyler
  • x-513-2472002-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4700 Ashwood Dr Ste 445 ; Cincinnati, OH 45241 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00860010987940 TyTek Medical Inc.	Clinical HypoHolder	2025-07-07
GUDID 00860010987902 TyTek Medical Inc.	Surgical HypoHolder	2025-07-07
GUDID 00860013471606 TyTek Medical Inc.	HypoFoam	2025-06-25
GUDID 00860010987926 TyTek Medical Inc.	HypoPan	2025-06-25
GUDID 00855204008167 TYTEK MEDICAL INC.	PneumoDart TM-317	2019-10-11
GUDID 00855204008099 TYTEK MEDICAL INC.	EZ GAUZE TM-215	2019-10-11
GUDID 00855204008082 TYTEK MEDICAL INC.	TYTEK TRAUMA BANDAGE TM-212	2019-10-11
GUDID 00855204008075 TYTEK MEDICAL INC.	TYTEK TRAUMA BANDAGE TM-206	2019-10-11
GUDID 00855204008068 TYTEK MEDICAL INC.	TYTEK TRAUMA BANDAGE TM-204	2019-10-11
GUDID 00855204008051 TYTEK MEDICAL INC.	TPAK TM-310	2019-10-11
GUDID 00855204008037 TYTEK MEDICAL INC.	Ptensys Bleeding Control Kits TM-401	2019-10-11
GUDID 00855204008020 TYTEK MEDICAL INC.	Ptensys Bleeding Control Station TM-400	2019-10-11
GUDID 00855204008013 TYTEK MEDICAL INC.	TVAC TM-909	2019-10-11
GUDID 00855204008006 TYTEK MEDICAL INC.	TPAK TM-303	2019-10-11
OHO TYTEK MEDICAL INC	TM-401 Ptensys Bleeding Control Kit	2018-09-07
OHO TYTEK MEDICAL INC	TM-400 Ptensys Bleeding Control Station	2018-09-07
PMN K133528 | JOH TYTEK MEDICAL INC	H&H Crico Tube	2014-11-10
PMN K133528 | JOH TYTEK MEDICAL INC	Crico Tube	2014-11-10
BSY TYTEK MEDICAL INC	TVAC Manual Suction Device	2011-06-14
NAB TYTEK MEDICAL INC	TM-215 EZ Gauze	2011-03-23
MRI TYTEK MEDICAL INC	TM-511 XTricate	2011-03-23
GAA TYTEK MEDICAL INC	TM-317 PneumoDart	2011-03-23
GAA TYTEK MEDICAL INC	TM-310 TPAK10	2011-03-23
GAA TYTEK MEDICAL INC	TM-303 Tension Pneumothorax Access Kit	2011-03-23
FQM TYTEK MEDICAL INC	TM-212 Abdominal Trauma Bandage	2011-03-23
FQM TYTEK MEDICAL INC	TM-206 6" Trauma Bandage	2011-03-23
FQM TYTEK MEDICAL INC	TM-204 4" Trauma Bandage	2011-03-23

Related Finance Registrations

CAGE Code	6TL45	TYTEK MEDICAL INC. TYTEK MEDICAL
S.A.M. Registration	6TL45 [78589992]	TYTEK MEDICAL INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020042239916	Ningpo ,China (Mainland) -> Los Angeles, California	BANDAGE . . . . .	282 CTN
2020012723187	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	POLYCARBONATE CABINET	125 CTN
201912169032	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SCISSORS	35 CTN
201910152292	Shanghai ,China (Mainland) -> Long Beach, California	BANDAGE GAUZE	285 CTN
2019081244611	Shanghai ,China (Mainland) -> Long Beach, California	BANDAGE GAUZE	285 CTN
2019042229798	Santa Barbara de Samana,Dominican Republic -> New York/Newark Area, Newark, New Jersey	TENSION PNEUMOTHORAX ACCESS KIT	60 CTN
2019041159454	Kaohsiung,China (Taiwan) -> Long Beach, California	CRICO CRICO TUBE #6.0 WITHOUT STERILE.	500 CTN
2018121454243	Kaohsiung,China (Taiwan) -> Long Beach, California	CRICO CRICO TUBE #6.0 WITHOUT STERILE.	188 CTN