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Elvation Medical GMBH: FDA-registered device maker in Kieselbronn Baden-Wurttemberg, Germany, 2 510(k) clearances

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

Elvation Medical GMBH is registered with the FDA (registration 3009212453) in Kieselbronn Baden-Wurttemberg, Germany. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2020. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009212453
Address: Ludwig-Wolf-Str. 6, Kieselbronn Baden-Wurttemberg, Germany, 75249
Owner or operator: ELvation Medical GmbH (10042279)
Roles: Exporter to the US
First device listed: November 7, 2012
Registered through: 2026
Brand names listed: 3000950, Mindray Z50, PiezoWave 2 MyACT, PiezoWave 2 Touch, Piezolith 3000 Triple Focus

Devices it lists

Device	Product code	Class	Role	Source
Lithotriptor, Extracorporeal Shock-Wave, Urological	LNS	2	Exporter to the US	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	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 2, 2020	K200251	Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 30, 2008	K072538	PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER	LNS	Substantially Equivalent	United Medical Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 2, 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.