Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064371

FEI Number

3002865793

Entity Name

MEDONE SURGICAL, INC.

City/State/Country

SARASOTA, FL, US

Establishment Address

670 TALLEVAST ROAD, SARASOTA, FL 34243, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MEDONE SURGICAL, INC. (Owner Number: 9039435)

Owner / Operator Contact Address

670 TALLEVAST ROAD, --, Sarasota, FL 34243, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Auricle MedOne MedOne MedOne MedOne EyeTech MicroDose MedOne AdvantEdge MedOne EyeTech MedOne

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	1999-10-27
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1999-10-27
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-08-04
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-02-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-04-27
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-27
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-12-06
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-02-05

Official Correspondent

BRUCE BECKSTEIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDONE SURGICAL, INC.

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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

Registration Number	Establishment Name	Location
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1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3021680161	BEAR-ENT, LLC	Malvern, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064371. Last updated year: 2026. Please use registration number 1064371 when referencing this establishment in official correspondence.