Fortune Medical Instrument Corp

FDA Filings

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

FDA Registration(s)

• Registration Number: 8022978
• FEI Number: 3006582718
• Name: Fanny Zhao
• Owner & Operator: FORTUNE MEDICAL INSTRUMENT CORP.
• Contact Address: 6 F., No. 29, Sec. 2, Jhongjheng E. Rd., Danshuei Dist,; New Taipei City TW-TPQ Taipei - District 251 TW
• Official Correspondent:
  • ABE - WANG
  • 886-2-26242233-x
• US Agent:
  • Fanny Zhao
  • J & F Technology Service LLC
  • 626 8619905
  • info@jf-yiliao.com
• Importing Logistics Registration:
  • Importer: SKY CROWN INT'L INC.
  • Address: 2750 Oregon Ct,.Unit M7. Torrance ,CA 90305 ; Inglewood, CA 90305 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2424 Morris Ave 818 Union ; Union, NJ 07083 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 14711182608313 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone T Drainage Set With Eyes	2023-11-01
GUDID 14711182608306 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone T Drainage Set With Eyes	2023-11-01
GUDID 14711182628762 FORTUNE MEDICAL INSTRUMENT CORP.	Rystora® Scar Sheets	2022-02-08
GUDID 14711182628755 FORTUNE MEDICAL INSTRUMENT CORP.	Rystora® Scar Sheets	2022-02-08
GUDID 04711182629236 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. reservoir, 100 cc, bottom outlet	2022-02-08
GUDID 04711182629229 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. reservoir, 400 cc, bottom outlet	2022-02-08
GUDID 04711182608163 FORTUNE MEDICAL INSTRUMENT CORP.	Rystora Skin Protector-Spray	2022-02-08
GUDID 04710961935391 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain Kit	2022-02-08
GUDID 04710961935384 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain Kit	2022-02-08
GUDID 04710961935377 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain Kit	2022-02-08
GUDID 04710961935360 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain	2022-02-08
GUDID 04710961935353 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain	2022-02-08
GUDID 04710961935346 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain	2022-02-08
GUDID 04710961935339 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain	2022-02-08
GUDID 04710961935322 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain	2022-02-08
GUDID 04710961935315 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain	2022-02-08
GUDID 04710961935186 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935162 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935148 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935131 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935124 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935117 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935100 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935094 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935087 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935070 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935063 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935056 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935049 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935032 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain Kit	2022-02-08
GUDID 04710961935025 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935018 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961935001 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961934998 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961934981 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961934974 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961934967 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-02-08
GUDID 04710961934912 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961934905 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961934899 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961934882 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961934875 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir (Top Outlet)	2022-02-08
GUDID 04710961934868 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961934851 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961934844 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-02-08
GUDID 04710961935407 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain Kit	2022-01-25
GUDID 04711182606541 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo Drain Kit with Bendable Trocar	2022-01-17
GUDID 04711182606497 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube+J connector	2022-01-17
GUDID 04711182606480 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube+J connector	2022-01-17
GUDID 04711182606473 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube+J connector	2022-01-17
GUDID 04711182606466 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone hubless Endo-drain (J Connector+Bendable Trocar)	2022-01-17
GUDID 04711182606459 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone hubless Endo-drain (J Connector+Bendable Trocar)	2022-01-17
GUDID 04711182606145 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo Drain Kit	2022-01-17
GUDID 04711182606121 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo Drain Kit	2022-01-17
GUDID 04711182606114 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo Drain Kit	2022-01-17
GUDID 04711182606107 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo Drain Kit	2022-01-17
GUDID 04711182606091 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube	2022-01-17
GUDID 04711182606084 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube	2022-01-17
GUDID 04711182606077 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube	2022-01-17
GUDID 04711182606053 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube	2022-01-17
GUDID 04711182606046 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube	2022-01-17
GUDID 04711182606039 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Hubless Endo-Drain Tube	2022-01-17
GUDID 04711182605551 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain Kit	2022-01-17
GUDID 04711182605544 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain Kit	2022-01-17
GUDID 04711182605537 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain	2022-01-17
GUDID 04711182605520 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain	2022-01-17
GUDID 04710961935841 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain Kit	2022-01-17
GUDID 04710961935834 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain Kit	2022-01-17
GUDID 04710961935827 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain Kit	2022-01-17
GUDID 04710961935810 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain Kit	2022-01-17
GUDID 04710961935803 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain	2022-01-17
GUDID 04710961935797 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain	2022-01-17
GUDID 04710961935780 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain	2022-01-17
GUDID 04710961935773 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Endo-Drain	2022-01-17
GUDID 04710961935766 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935759 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935742 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935735 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935728 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935711 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935704 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935698 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935681 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935674 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935667 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935650 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935643 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935636 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935629 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935612 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain Kit	2022-01-17
GUDID 04710961935605 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935599 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935582 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935575 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935568 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935551 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Round Drain	2022-01-17
GUDID 04710961935421 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain Kit	2022-01-17
GUDID 04710961935414 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Vac-Drain Kit	2022-01-17
GUDID 04710961934950 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone Flat Drain	2022-01-17
GUDID 04710961934837 FORTUNE MEDICAL INSTRUMENT CORP.	Silicone C.W.V. Reservoir	2022-01-17
PMN K190114 | PIF Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	FLEXI-SEAL PROTECT PLUS FMS WITH ENFIT CONNECTOR; FLEXI-SEAL PROTECT PLUS FMS WITH LUER CONNECTOR	2019-11-26
PMN K190114 | KNT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	FLEXI-SEAL PROTECT PLUS FMS WITH ENFIT CONNECTOR; FLEXI-SEAL PROTECT PLUS FMS WITH LUER CONNECTOR	2019-11-26
PMN K150350 | KNT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Flexi-Seal? SIGNAL? Fecal Management System	2015-10-15
PMN K150350 | KNT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Flexi-Seal Signal FMS Zeolite	2015-10-15
PMN K112342 | KNT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Flexi-Seal? SIGNAL? Fecal Management System	2015-10-15
PMN K112342 | KNT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Flexi-Seal Signal FMS	2015-10-15
CAT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Silicone Nasal Cannula	2015-09-22
EMX Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Silicone Nasal Epistaxis Balloon	2013-01-17
GCD Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	DRAIN TUBE	2006-03-24
PMN K980919 | GBM Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE FOLEY CATHETER	2006-01-30
PMN K980919 | EZL Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE FOLEY CATHETER	2006-01-30
PMN K980917 | GCA Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Y	2006-01-30
PMN K980917 | GCA Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	T-Y DRAINAGE TUBE	2006-01-30
PMN K980917 | GCA Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE T	2006-01-30
PMN K022112 | KNT Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	STOMACH (GASTRIC) TUBING	2006-01-30
PMN K021193 | HDB Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE VACUUM SUCTION	2006-01-30
PMN K014002 | KOB Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	ALL SILICONE SUPRAPUBIC CATHETER	2006-01-30
KGZ Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	MEDICAL TUBE	2006-01-30
GCY Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE C.W.V. RESERVIOR	2006-01-30
GBW Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	ALL SILICONE PERITONEAL CATHETER	2006-01-30
GBS Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	ALL SILICONE THORA	2006-01-30
GBP Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE DRAIN CATHETER	2006-01-30
CAE Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	Silicone airway (laryngeal)	2006-01-30
BYX Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	OXYGEN TUBING	2006-01-30
PMN K022112 FORTUNE MEDICAL INSTRUMENT CORP.	FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020	2003-04-03
PMN K021193 FORTUNE MEDICAL INSTRUMENT CORP.	FORTUNE SILICONE VACUUM SUCTION, MODEL #1300	2003-02-12
PMN K014002 FORTUNE MEDICAL INSTRUMENT CORP.	ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890	2002-03-04
PMN K980917 FORTUNE MEDICAL INSTRUMENT CORP.	ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR	1998-05-27
PMN K980919 FORTUNE MEDICAL INSTRUMENT CORP.	ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER	1998-03-31
BSY Fanny Zhao [FORTUNE MEDICAL INSTRUMENT CORP.]	SILICONE SUCTION CATHETER	1988-11-17

Related Finance Registrations

NCAGE Code	SG589	FORTUNE MEDICAL INSTRUMENT CORP.
CAGE Code	SG589	FORTUNE MEDICAL INSTRUMENT CORP.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092871488	Shilong,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL PROTECT FMS,US HS CODE 9018.39 4500 PCS=15 PLTS . . .	4500 PCS
2020092649927	Shilong,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL SIGNAL RX W ZEOLITE, US HS CODE 9018.39 PO #4500109844 12000 PCS = 40 PLTS .	12000 PCS
2020092658018	All Other China (Taiwan) Ports,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL PROTECT PLUS FMS,ENFIT AND LUER HS. CODE 9018.39 1,680 PCE = 6 PLTS .	1680 PCS
2020092147925	Kaohsiung,China (Taiwan) -> Tacoma, Washington	CLEAR VIEW FOLEY CATHETER	54 CTN
2020091813935	Shilong,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL PROTECT FMS,US HS CODE 9018.39 PO#4500110845 4500 PCS=15 PLTS . .	4500 PCS
2020091822371	Shilong,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL SIGNAL RX W ZEOLITE, US PO#4500118123 HS CODE 9018.39 12000 PCS=40 PLTS .	12000 PCS
2020090926531	Kaohsiung,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL SIGNAL RX W ZEOLITE, US HS CODE 9018.39 PO#4500113319 12,000 PCS = 40 PLTS .	12000 PCS
2020090926507	Kaohsiung,China (Taiwan) -> Los Angeles, California	FLEXI-SEAL SIGNAL RX W ZEOLITE, US HS CODE 9018.39 12,000 PCS=40 PLTS . .	12000 PCS