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Fortune Medical Instrument Corp.: FDA-registered device maker in Taoyuan City, Taiwan, 6 510(k) clearances

Fortune Medical Instrument Corp. is registered with the FDA (registration 8022978) in Taoyuan City, Taiwan. It lists 27 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 3, 2003. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
8022978
FEI number
3006582718
Address
No. 256, Changchun 2nd Rd. Jhongli Dist., Taoyuan City, Taiwan, 320
Owner or operator
FORTUNE MEDICAL INSTRUMENT CORP. (8022978)
Roles
Contract manufacturer, Manufacturer
First device listed
November 17, 1988
Registered through
2026
Brand names listed
"Fortune" FixPad, "Fortune" Silicone Hematuria Catheter, ALL SILICONE PERITONEAL CATHETER, ALL SILICONE SUPRAPUBIC CATHETER, ALL SILICONE THORA, DRAIN TUBE, FLEXI-SEAL PROTECT PLUS FMS WITH ENFIT CONNECTOR; FLEXI-SEAL PROTECT PLUS FMS WITH LUER CONNECTOR, Flexi-Seal Signal FMS and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Contract manufacturer, Manufactureraccessdata.fda.gov
Balloon, EpistaxisEMX1Contract manufacturer, Manufactureraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Manufactureraccessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGCA2Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufactureraccessdata.fda.gov
Catheter, Multiple LumenGBP1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, PeritonealGBW1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Suprapubic (And Accessories)KOB2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, UrethralGBM2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, UrologicalKOD2Manufactureraccessdata.fda.gov
Catheter, Ventricular, General & Plastic SurgeryGBS1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract manufacturer, Manufactureraccessdata.fda.gov
Connector, CatheterGCD1Contract manufacturer, Manufactureraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Manufactureraccessdata.fda.gov
Extractor, Vacuum, FetalHDB2Contract manufacturer, Manufactureraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Contract manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Protector, OstomyEXE1Manufactureraccessdata.fda.gov
Silicone Hydrogel For Scar ManagementPFP1Manufactureraccessdata.fda.gov
Snare, SurgicalGAE1Manufactureraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Manufactureraccessdata.fda.gov
Topical Approximation SystemMZR1Manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract manufacturer, Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 3, 2003K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020KNTSubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov
February 12, 2003K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300HDBSubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov
October 1, 2002K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865EZLSubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov
March 4, 2002K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890KOBSubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov
May 27, 1998K980917ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIRGCASubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov
March 31, 1998K980919ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETEREZLSubstantially EquivalentFortune Medical Instrument Corp.accessdata.fda.gov

Compare with other makers

Updated April 3, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.