Data / Medical devices / Germany / Kuehne GMBH

Kuehne GMBH: FDA-registered device maker in Dortmund North Rhine-Westphalia, Germany, 16 510(k) clearances and 1 PMA approval

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

Kuehne GMBH is registered with the FDA (registration 3009963139) in Dortmund North Rhine-Westphalia, Germany. It lists 11 device types. The FDA files 16 510(k) clearances and 1 PMA approval under its listings, the newest dated May 1, 2020. Registered through 2027. 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 Kuehne GMBH

FDA registration number: 3009963139
Address: Beratgerstr. 19, Dortmund North Rhine-Westphalia, Germany, 44149
Owner or operator: Kuehne GmbH (10088909)
Roles: Exporter to the US, Repackager or relabeler
First device listed: October 24, 2023
Registered through: 2027
Brand names listed: Allura Xper FD20/20, BIPS Parts, GE Discovery 690 PET/CT, GE Discovery IQ 5R PET-CT, GE Discovery NM/ CT 670, GE Discovery PET/CT, GE Innova 2100 IQ, GE OPTIMA MR450W and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US	accessdata.fda.gov
Full Field Digital, System, X-Ray, Mammographic	MUE	2	Exporter to the US	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomographic	IZF	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	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
May 1, 2020	K200917	Azurion R2.1	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
November 3, 2016	K162268	Senographe Pristina	MUE	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
September 18, 2014	K141477	DISCOVERY IQ	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
August 30, 2013	K131576	OPTIMA CT660	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
May 21, 2013	K130842	ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES	IZI	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 17, 2013	K130885	MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT	LNH	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
March 13, 2013	K123522	OPTIMA MR450W	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
July 20, 2011	K110227	OPTIMA CT660	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
December 10, 2009	K093514	DISCOVERY MODEL NM/CT 670	KPS	Substantially Equivalent	Ge Medical Systems F.I. Haifa	accessdata.fda.gov
June 18, 2009	K090745	ARTIS ZEE / ZEEGOS WITH SW VC14	IZI	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 12, 2008	K081496	OPTIMA PET/CT 560	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
August 9, 2005	K051967	REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS	KPR	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
May 23, 2005	K051170	GEMINI GXL	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
March 11, 2005	K050489	INNOVA 2100	OWB	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 22, 2004	K041543	GE DISCOVERY ST	KPS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
December 9, 2003	K033737	ALLURA XPER FD20	OWB	Substantially Equivalent	Philips Medical Systems North America, Inc.	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
January 28, 2000	P990066	GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	MUE	36	November 5, 2010	accessdata.fda.gov

Compare with other makers

Updated May 1, 2020. 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.