Data / Medical devices / United States / Hurricane Medical
Hurricane Medical: FDA-registered device maker in Bradenton, FL, United States, 1 510(k) clearance
Hurricane Medical is registered with the FDA (registration 1064005) in Bradenton, FL, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 10, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1064005
- FEI number
- 3002590787
- Address
- 5315 Lena Road, Bradenton, FL, United States, 34211
- Owner or operator
- HURRICANE MEDICAL (9036203)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 20, 1999
- Registered through
- 2026
- Brand names listed
- ANESTHESIA PERIBULBAR, EYE SHIELD, FILTER, Hurricane Medical Marker Pads and Marker Pens, IRRIGATING CYSTOTOME, IRRIGATION AND ASPIRATION CANNULA, Incise Film, LIGHT SHIELD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cystotome | HNY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Sclera | HMQ | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 1 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 1999 | K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | HOZ | Substantially Equivalent | Hurricane Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Marker, Sclera
- All makers of Tape And Bandage, Adhesive
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Cystotome
- All makers of Cannula, Ophthalmic
- All makers of Lens, Guide, Intraocular
Updated May 10, 1999. 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.