Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042941992

FEI Number

3042941992

Entity Name

Edwards Lifesciences Holding B.V.

City/State/Country

AMSTERDAM Noord-Holland, NL

Establishment Address

CENTERPOINT 1, 4TH FLOOR, HOOGOORDDREEF 60, AMSTERDAM Noord-Holland 1101 BE, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Becton, Dickinson and Company (Owner Number: 10093301)

Owner / Operator Contact Address

17200 Laguna Canyon Road, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122381

PMA Number

N/A

All Registered Proprietary Names

EV1000 Clinical Platform NI EV1000NI Clearsight EV1000 Non-invasive Clearsight system Clearsight finger cuff Nexfin Model 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-05-06
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2025-05-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-05-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-05-06
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2025-05-06

Official Correspondent

No official correspondent registered.

US Agent Details

Karen O'Leary Business: BECTON, DICKINSON AND COMPANY Email: karen.oleary2@bd.com Phone: (949) 6109179

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
2648045	EDWARDS LIFESCIENCES TECHNOLOGY SARL	ANASCO, PR, US
9615817	CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG	HAINA San Cristobal, DO
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

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3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042941992. Last updated year: 2026. Please use registration number 3042941992 when referencing this establishment in official correspondence.