Hurricane Medical
Bradenton, FL, US
HURRICANE MEDICAL appears in FDA device records in Bradenton, FL. FDA records list 3 510(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 3 510(k) clearances for Hurricane Medical between 1999 and 2000. The busiest year on record is 1999, with 2. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993361 | TUBING EXTENSION SET | MSR | Substantially Equivalent | |
| K990672 | LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET | OKS | Substantially Equivalent | |
| K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | HOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1064005 | 3002590787 | HURRICANE MEDICAL | 5315 LENA ROAD, BRADENTON, FL 34211 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HMXCannula, Ophthalmic
- HNYCystotome
- OKSLacrimal Stents And Intubation Sets
- KYBLens, Guide, Intraocular
- HMQMarker, Sclera
- GAANeedle, Aspiration And Injection, Disposable
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- HOZSponge, Ophthalmic
- KGXTape And Bandage, Adhesive
- MSRTubing, Replacement, Phacofragmentation Unit
- JRLUnit, Filter, Membrane
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