Data / Medical devices / Switzerland / Ethicon Sarl

Ethicon Sarl: FDA-registered device maker in Neuchatel, Switzerland, 2 PMA approvals

Name: Ethicon Sarl FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ethicon Sarl is registered with the FDA (registration 3003702646) in Neuchatel, Switzerland. It lists 4 device types. The FDA files 2 PMA approvals under its listings, the newest dated September 15, 1989. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ethicon Sarl

FDA registration number: 3003702646
Address: Puits Godet 20, Neuchatel, Switzerland, 2000
Owner or operator: ETHICON INC. (2210968)
Roles: Contract manufacturer, Manufacturer
First device listed: April 24, 2008
Registered through: 2026
Brand names listed: GYNECARE INTERCEED Absorbable Adhesion Barrier, GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM, GYNECARE TVT ABBREVO Continence System, GYNECARE TVT ABBREVO and GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator, GYNECARE TVT Introducer and Catheter Guide and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Absorbable Hemostatic, Non-Collagen Based	LMG	3	Manufacturer	accessdata.fda.gov
Barrier, Absorbable, Adhesion	MCN	3	Manufacturer	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	PWJ	2	Contract manufacturer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	OTN	2	Contract manufacturer	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 15, 1989	P880047	INTERCEED TC7 ABSORBABLE ADHESION BARRIER	MCN	65	June 25, 2026	accessdata.fda.gov
October 14, 1960	N12159	SURGICEL BRAND ABSORBABLE HEMOSTAT	LMG	120	July 28, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 11, 2024	94831	Class II	Ongoing	SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961	Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.	accessdata.fda.gov

Compare with other makers

Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.