Leica Microsystems (Schweiz) AG

HEERBRUGG Sankt Gallen, CH

LEICA MICROSYSTEMS (SCHWEIZ) AG appears in FDA device records in HEERBRUGG Sankt Gallen, CH. FDA records list 4 510(k) clearances between 2008-05-09 and 2019-03-28, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 2
Registered establishments: 1

510(k) clearance history

FDA records hold 4 510(k) clearances for Leica Microsystems (Schweiz) AG between 2008 and 2019. The busiest year on record is 2008, with 1. The most recent is 2019, with 1.

Clearances by year, as a table

510(k) clearance decisions for Leica Microsystems (Schweiz) AG, by decision year
Year	Clearances
2008	1
2017	1
2018	1
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
DEN180024	Leica FL400	QFX	Unknown	2019-03-28
K181537	GLOW800	IZI	Substantially Equivalent	2018-09-07
K170239	Leica FL560	IZI	Unknown	2017-07-05
K080612	LEICA FL800	IZI	Substantially Equivalent	2008-05-09

Registered establishments

FDA registered establishments for Leica Microsystems (Schweiz) AG, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3003974370	3003974370	LEICA MICROSYSTEMS (SCHWEIZ) AG	MAX SCHMIDHEINY-STRASSE 201, HEERBRUGG Sankt Gallen 9435 CH	2026	EPT FSO HRM IZI QFX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2177-2013	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.	Class II	2012-12-18	Terminated
Z-2176-2013	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.	Class II	2012-12-18	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain