Fortune Medical Instrument Corp.
Taoyuan City, TW
FORTUNE MEDICAL INSTRUMENT CORP. appears in FDA device records in Taoyuan City, TW. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Fortune Medical Instrument Corp. between 1998 and 2003. The busiest year on record is 1998, with 2. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022112 | FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 | KNT | Substantially Equivalent | |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | HDB | Substantially Equivalent | |
| K021142 | ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 | EZL | Substantially Equivalent | |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | KOB | Substantially Equivalent | |
| K980917 | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR | GCA | Substantially Equivalent | |
| K980919 | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER | EZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8022978 | 3006582718 | FORTUNE MEDICAL INSTRUMENT CORP. | No. 256, Changchun 2nd Rd., Taoyuan City 320 TW | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- CAEAirway, Oropharyngeal, Anesthesiology
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- EMXBalloon, Epistaxis
- NECBandage, Liquid, Skin Protectant
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- CATCannula, Nasal, Oxygen
- GBPCatheter, Multiple Lumen
- GBWCatheter, Peritoneal
- EZLCatheter, Retention Type, Balloon
- KOBCatheter, Suprapubic (And Accessories)
- GBMCatheter, Urethral
- KODCatheter, Urological
- GBSCatheter, Ventricular, General & Plastic Surgery
- BSYCatheters, Suction, Tracheobronchial
- GCDConnector, Catheter
- MDAElastomer, Silicone, For Scar Management
- HDBExtractor, Vacuum, Fetal
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- BYGMask, Oxygen
- EXEProtector, Ostomy
- PFPSilicone Hydrogel For Scar Management
- GAESnare, Surgical
- KOXSolvent, Adhesive Tape
- MZRTopical Approximation System
- KNTTubes, Gastrointestinal (And Accessories)
- BYXTubing, Pressure And Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain