Data / Medical devices / Germany / S.I.M.E.O.N. MEDICAL GMBH & Co.KG

S.I.M.E.O.N. MEDICAL GMBH & Co.KG: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 2 510(k) clearances

Name: S.I.M.E.O.N. MEDICAL GMBH & Co.KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

S.I.M.E.O.N. MEDICAL GMBH & Co.KG is registered with the FDA (registration 3006223081) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 7, 2006. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006223081
Address: In Grubenacker 18, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator: S.I.M.E.O.N. MEDICAL GmbH & Co. KG (9093739)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 12, 2012
Registered through: 2026
Brand names listed: Light, Surgical_Wall Mounted, Sim. LED 5000 MC, Sim. LED 5000 SC, Sim. LED 7000 MC, Sim. LED 7000 SC, Sim.CAM 4K, Sim.CAM 4K Wireless, Sim.CAM HD and more

Devices it lists

Device	Product code	Class	Role	Source
Camera, Surgical And Accessories	KQM	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Light, Surgical, Ceiling Mounted	FSY	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Light, Surgical, Floor Standing	FSS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Complaint file establishment, Manufacturer	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
April 7, 2006	K060802	VISUM LED SURGICAL LIGHTING SYSTEM	FSY	Substantially Equivalent	Stryker Communications Corp.	accessdata.fda.gov
August 12, 2003	K031068	STRYKER VISUM SURGICAL LIGHTING SYSTEM	FSY	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov

Compare with other makers

Updated April 7, 2006. 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.