Data / Medical devices / Germany / Zimmer Medizinsysteme GMBH

Zimmer Medizinsysteme GMBH: FDA-registered device maker in NEU-ULM Bavaria, Germany, 18 510(k) clearances

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

Zimmer Medizinsysteme GMBH is registered with the FDA (registration 8010720) in NEU-ULM Bavaria, Germany. It lists 15 device types. The FDA files 18 510(k) clearances under its listings, the newest dated January 16, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010720
FEI number: 7759
Address: Junkersstrasse 9, NEU-ULM Bavaria, Germany, 89231
Owner or operator: ZIMMER MEDIZINSYSTEME GMBH (8010720)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 13, 1984
Registered through: 2026
Brand names listed: CRYO 5, CRYO 6, CRYO 6PT, CoolTone, Cryo 7, Cryo Mini, CryoOne, Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6, Cryo C and more

Devices it lists

Device	Product code	Class	Role	Source
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	IMJ	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Equipment, Traction, Powered	ITH	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Manufacturer	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	2	Exporter to the US, 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
January 16, 2026	K253408	CoolTone	NGX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
July 21, 2024	K240347	PTG-05	NGX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
July 15, 2024	K240178	RFG-01	PBX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
October 24, 2023	K230472	Sonopuls 190	IMI	Substantially Equivalent	Enraf-Nonius, B.V.	accessdata.fda.gov
October 5, 2023	K230780	MFG-05	KPI	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
May 25, 2023	K213256	ThermoTK	PBX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
May 16, 2023	K222912	c1Trac	ITH	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
April 1, 2022	K220601	CoolTone	NGX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
February 4, 2022	K220020	Cryo 7	GEX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
February 19, 2021	K203488	emField	IPF	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
November 15, 2019	K192940	CoolTone	NGX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
June 21, 2019	K182963	emFieldPro	NGX	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
November 14, 2016	K161862	ThermoPro	IMJ	Substantially Equivalent	Zimmer Medizinsysteme GmbH	accessdata.fda.gov
October 24, 2014	K141564	OPTON PRO	ILY	Substantially Equivalent	Zimmer Medizinsystems GmbH	accessdata.fda.gov
May 21, 2014	K140340	SKINTACT	GXY	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
August 7, 2012	K121059	SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM	IMG	Substantially Equivalent	Zimmer Medizinsystems GmbH	accessdata.fda.gov
April 4, 2008	K080735	CRYOMINI	GEX	Substantially Equivalent	Zimmer Elektromedizin GmbH	accessdata.fda.gov
February 24, 2006	K060395	CRYO, MODEL V6.0	GEX	Substantially Equivalent	Zimmer Elektromedizin GmbH	accessdata.fda.gov

Compare with other makers

Updated January 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.