Trophy

Marne La Vallee Ile-de-France, FR

Trophy appears in FDA device records in Marne La Vallee Ile-de-France, FR. FDA records list 15 510(k) clearances between 2008-02-11 and 2020-04-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 15
PMA records: 0
Recall records: 5
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Trophy carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Trophy SASenforcement report, recall

510(k) clearance history

FDA records hold 15 510(k) clearances for Trophy between 2008 and 2020. The busiest year on record is 2008, with 3. The most recent is 2020, with 2.

Clearances by year, as a table

510(k) clearance decisions for Trophy, by decision year
Year	Clearances
2008	3
2010	1
2011	1
2012	2
2014	2
2015	2
2018	2
2020	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K193390	CS Model+	PNN	Substantially Equivalent	2020-04-02
K200183	CS 9600	OAS	Substantially Equivalent	2020-03-13
K181136	CS 9600	OAS	Substantially Equivalent	2018-05-24
K173622	CS Imaging	LLZ	Substantially Equivalent	2018-01-16
K151087	CS 8100SC, CS8100SC Access	MUH	Substantially Equivalent	2015-08-21
K151837	CS 3D Imaging	LLZ	Substantially Equivalent	2015-08-19
K141607	DENTAL IMAGING SOFTWARE	LLZ	Substantially Equivalent	2014-09-18
K133406	CS 8100 3D	OAS	Substantially Equivalent	2014-03-14
K120975	CS 8100 CS 8100 ACCESS	MUH	Substantially Equivalent	2012-06-22
K113419	CS IMAGING	LLZ	Substantially Equivalent	2012-02-16
K103659	CS 9300, CS 9300C	OAS	Substantially Equivalent	2011-08-18
K093478	KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM	MUH	Substantially Equivalent	2010-04-26
K082972	KODAK 9500	MUH	Substantially Equivalent	2008-12-05
K080889	KODAK 9000C EXTRAORAL IMAGING SYSTEM	MUH	Substantially Equivalent	2008-04-29
K073435	KODAK 9000, KODAK 9000 3D	MUH	Substantially Equivalent	2008-02-11

Registered establishments

FDA registered establishments for Trophy, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
8020825	7695	Trophy	4 rue F. Pelloutier, Marne La Vallee Ile-de-France 77435 FR	2026	EAP EHD KQM LLZ MUH MYN OAS

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1627-2023	CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.	Device failed to function as intended and/or failed to conform to their design specifications.	Class II	2021-07-21	Open, Classified
Z-1095-2013	CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.	There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.	Class II	2012-09-18	Terminated
Z-1094-2013	CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.	There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.	Class II	2012-09-18	Terminated
Z-1000-2013	CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.	There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.	Class II	2012-09-18	Terminated
Z-0999-2013	CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.	There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.	Class II	2012-09-18	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain