Data / Medical devices / Switzerland / Leica Microsystems (schweiz) AG

Leica Microsystems (schweiz) AG: FDA-registered device maker in HEERBRUGG Sankt Gallen, Switzerland, 4 510(k) clearances

Name: Leica Microsystems (schweiz) AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Leica Microsystems (schweiz) AG is registered with the FDA (registration 3003974370) in HEERBRUGG Sankt Gallen, Switzerland. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 28, 2019. 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 Leica Microsystems (schweiz) AG

FDA registration number: 3003974370
Address: Max Schmidheiny-Strasse 201, HEERBRUGG Sankt Gallen, Switzerland, 9435
Owner or operator: Leica Microsystems CMS GmbH (10054809)
Roles: Specification developer
First device listed: May 8, 2017
Registered through: 2026
Brand names listed: ARveo 8, ARveo 8x, GLOW800, Leica FL400, Leica FL560, Leica FL560 Procedure Kit, Leica FL800 ULT, Leica M220 F12 and more

Devices it lists

Device	Product code	Class	Role	Source
Diagnostic Neurosurgical Microscope Filter	QFX	2	Specification developer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Specification developer	accessdata.fda.gov
Microscope, Surgical	EPT	1	Specification developer	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Specification developer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 28, 2019	DEN180024	Leica FL400	QFX	Unknown	Leica Microsystems (Schweiz) AG	accessdata.fda.gov
September 7, 2018	K181537	GLOW800	IZI	Substantially Equivalent	Leica Microsystems (Schweiz) AG	accessdata.fda.gov
July 5, 2017	K170239	Leica FL560	IZI	Unknown	Leica Microsystems (Schweiz) AG	accessdata.fda.gov
August 19, 2014	K141136	LEICA FL800	IZI	Substantially Equivalent	Leica Biosystems Richmond	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
December 18, 2012	64601	Class II	Terminated	Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.	The brake in the Z axis and/or brakes in the AB and C axes failed during installation.	accessdata.fda.gov

Compare with other makers

Updated March 28, 2019. 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.