Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064005

FEI Number

3002590787

Entity Name

HURRICANE MEDICAL

City/State/Country

BRADENTON, FL, US

Establishment Address

5315 LENA ROAD, BRADENTON, FL 34211, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HURRICANE MEDICAL (Owner Number: 9036203)

Owner / Operator Contact Address

5315 LENA ROAD, --, Bradenton, FL 34211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K990671

PMA Number

N/A

All Registered Proprietary Names

IRRIGATING CYSTOTOME IRRIGATION AND ASPIRATION CANNULA Incise Film UNIT FILTER MEMBRANE SURGICAL GLIDE Wick, Spear, Sponge, Light Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNY	Cystotome	Ophthalmic	Class 1	886.4350	1999-01-20
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-01-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-11-19
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2000-01-18
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	1999-09-23
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2007-10-18

Official Correspondent

Gabriel Rodriguez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HURRICANE MEDICAL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A

Similar Registrations

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3003860763	BILINK INTERNATIONAL INC.	JODHPUR Rajasthan, IN
2523835	Alcon Research, LLC	Sinking Spring, PA, US
3004475955	ISCON SURGICALS, LTD.	JODHPUR Rajasthan, IN
3007583964	TOTAL TITANIUM, INC.	Red Bud, IL, US
3008770252	NOVO SURGICAL, INC.	Westmont, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064005. Last updated year: 2026. Please use registration number 1064005 when referencing this establishment in official correspondence.