Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003916417

FEI Number

3003910417

Entity Name

BECTON DICKINSON IND. CIRURGICAS LTDA.

City/State/Country

CURITIBA Parana, BR

Establishment Address

RUA CYRO CORREIA PEREIRA 550, CURITIBA Parana 81170-230, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161170

PMA Number

N/A

All Registered Proprietary Names

Eclipse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

John Roberts Email: john_w_roberts@bd.com Phone: (201) 8474760

Related Public Records

Same Entity

Becton Dickinson and Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL
9614033	BECTON DICKINSON DE MEXICO	CUAUTITLAN, IZCALLI Queretaro, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003916417. Last updated year: 2026. Please use registration number 3003916417 when referencing this establishment in official correspondence.