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Medi-Globe GMBH: FDA-registered device maker in VELEN North Rhine-Westphalia, Germany, 6 510(k) clearances

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

Medi-Globe GMBH is registered with the FDA (registration 3011146996) in VELEN North Rhine-Westphalia, Germany. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011146996
Address: Logistics Center Sudring 21, VELEN North Rhine-Westphalia, Germany, 46342
Owner or operator: MEDI-GLOBE GMBH (9011628)
Roles: Exporter to the US
First device listed: September 22, 2005
Registered through: 2026
Brand names listed: Clear View, ClickTip, Endoflux Biliary & Pancreatic Stent Sets, Injectra, Optimizer Polyp Trap, Orbit-Snare, Pro Control, RotaSnare and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Exporter to the US	accessdata.fda.gov
Snare, Flexible	FDI	2	Exporter to the US	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	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
April 16, 2026	K251658	Endoflux Biliary & Pancreatic Stent Sets	FGE	Substantially Equivalent	Medi-Globe GmbH	accessdata.fda.gov
May 15, 2014	K133763	SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM	FCG	Substantially Equivalent	Medi-Globe Corporation	accessdata.fda.gov
March 20, 2009	K083802	SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025	FCG	Substantially Equivalent	Medi-Globe Corporation	accessdata.fda.gov
January 31, 2007	K070129	SONOTIP II ULTRASOUND NEEDLE SYSTEM	FCG	Substantially Equivalent	Medi-Globe Corporation	accessdata.fda.gov
July 3, 2006	K061222	INJECTRA INJECTION NEEDLE	FBK	Substantially Equivalent	Medi-Globe Corp.	accessdata.fda.gov
May 26, 1995	K943935	GIP/MEDI-GLOBE POLYPECTOMY SNARES	FDI	Substantially Equivalent	Medi-Globe Corp.	accessdata.fda.gov

Compare with other makers

Updated April 16, 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.