Data / Medical devices / Belgium / GMED Healthcare BVBA ( a Johnson & Johnson Company)

GMED Healthcare BVBA ( a Johnson & Johnson Company): FDA-registered device maker in Courcelles Luxembourg, Belgium, 30 510(k) clearances and 2 PMA approvals

Name: GMED Healthcare BVBA ( a Johnson & Johnson Company) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GMED Healthcare BVBA ( a Johnson & Johnson Company) is registered with the FDA (registration 3014272734) in Courcelles Luxembourg, Belgium. It lists 16 device types. The FDA files 30 510(k) clearances and 2 PMA approvals under its listings, the newest dated January 9, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3014272734
Address: European Distribution Centre Rue du Luxembourg 5, Courcelles Luxembourg, Belgium, 6180
Owner or operator: ETHICON INC. (2210968)
Roles: Exporter to the US
First device listed: November 9, 2011
Registered through: 2026
Brand names listed: ACUNAV 8F-90, ACUNAV G 10F-90 CATHETER, ACUNAV G 8F-90 CATHETER, AcuNav 10F-90 Catheter, Artisyn Y-Shaped Mesh, BI-MENTUM Cemented Cup, BI-MENTUM PE Liner, BI-MENTUM Plus Cup and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Absorbable Hemostatic, Collagen Based	LMF	3	Exporter to the US	accessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen With Polymeric Additives	SGV	3	Exporter to the US	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	PWJ	2	Exporter to the US	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Absorbable, Staple Line Reinforcement	OXC	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	OTO	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	OTN	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Chemical	MLR	2	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Exporter to the US	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	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
January 9, 2026	K252906	ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)	OXC	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
September 16, 2022	K221343	ECHELON ENDOPATH Staple Line Reinforcement	OXC	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
September 17, 2020	K201686	GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide	OTN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 14, 2019	K190937	Echelon Endopath Staple Line Reinforcement	OXC	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
June 27, 2019	K183183	VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture	GAM	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 11, 2018	K181744	BI-MENTUM dual mobility system	LZO	Substantially Equivalent	Serf	accessdata.fda.gov
August 10, 2018	K181151	GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System	PWJ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 6, 2018	K173019	GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar	PWJ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
July 2, 2018	K180910	ULTRAPRO Mesh and ULTRAPRO ADVANCED	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 28, 2018	K173162	GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide	PWJ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 1, 2018	K180238	CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT	DQK	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
November 3, 2017	K172054	Materialise Glenoid Positioning System	KWS	Substantially Equivalent	Materialise NV	accessdata.fda.gov
October 23, 2014	K141560	ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
May 30, 2014	K133198	ULTRAPRO COMFORT PLUG	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
March 12, 2014	K140318	SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER	OBJ	Substantially Equivalent	Biosense Webster	accessdata.fda.gov
August 23, 2013	K132054	GYNECARE TVT EXACT CONTINENCE SYSTEM	OTN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 11, 2012	K113205	ARTISYN Y-SHAPED MESH	OTO	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
November 18, 2011	K112050	SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER	OBJ	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
July 1, 2010	K100936	GYNECARE TVT ABBREVO CONTINENCE SYSTEM	OTN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 7, 2009	K092064	SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12	OBJ	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
November 29, 2007	K071385	STERRAD 100NX STERILIZER	MLR	Substantially Equivalent	Advanced Sterilization Products	accessdata.fda.gov
June 29, 2007	K071234	ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F	OBJ	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 5, 2007	K071249	ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
April 17, 2007	K070224	ULTRAPRO PLUG	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 11, 2006	K061533	PROCEED VENTRAL PATCH	FTL	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
April 22, 2005	K042116	STERRAD NX STERILIZER	MLR	Substantially Equivalent	Advanced Sterilization Products	accessdata.fda.gov
December 8, 2003	K033568	GYNECARE TVT OBTURATOR SYSTEM	OTN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
October 26, 2001	K012628	GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM	OTN	Substantially Equivalent	Gynecare Center	accessdata.fda.gov
June 15, 2000	K991999	STERRAD 100S STERILIZER	MLR	Substantially Equivalent	Advanced Sterilization Products	accessdata.fda.gov
August 28, 1998	K982740	CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S	DYB	Substantially Equivalent	Cordis Webster, 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
December 15, 2025	P240035	ETHIZIA	SGV	6	August 27, 2026	accessdata.fda.gov
September 30, 1999	P990004	SURGIFOAM ABSORBABLE GELATIN SPONGE, USP	LMF	79	September 18, 2026	accessdata.fda.gov

Compare with other makers

Updated August 27, 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.