Johnson & Johnson MEDICAL GmbH

FDA Device Registration & Listing · NORDERSTEDT Schleswig-Holstein, DE · Registration 3002294946

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002294946
FEI Number
3002294946
Entity Name
Johnson & Johnson MEDICAL GmbH
City/State/Country
NORDERSTEDT Schleswig-Holstein, DE
Establishment Address
ROBERT-KOCH-STRASSE 1, NORDERSTEDT Schleswig-Holstein 22851, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ETHICON INC. (Owner Number: 2210968)
Owner / Operator Contact Address
1000 US Highway 202 S., Raritan, NJ 08869, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180910
PMA Number
N/A

All Registered Proprietary Names

EES - ECHELON ENDOPATH™ Staple Line Reinforcement Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture PURSE STRING CLAMP Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture ENDOPATH SELF-RIGH SELF RIGHTING NEEDLE HOLDER PDS™ II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture PROCEED VENTRAL PATCH ULTRAPRO PLUG ECHELON ENDOPATH Staple Line Reinforcement Ethicon PHYSIOMESH Open Flexible Composite Mesh ULTRAPRO HERNIA SYSTEM ECHELON ENDOPATH Staple Line Reinforcement PDS PLATES PDS Flexible Plates ULTRAPRO Comfort Plug PROCEED SURGICAL MESH ULTRAPRO ADVANCED Mesh ULTRAPRO Mesh

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2026-01-16
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2015-05-19
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-03-13
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2018-12-12
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1998-08-31
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2020-01-02
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2020-01-02
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-11-09
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-11-09
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2024-09-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-11-10
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2011-11-09
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2020-03-04
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2010-03-10
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-06-12
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-01-26
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-07-23

Official Correspondent

Reynaldo Librojo

US Agent Details

Reynaldo Librojo Business: ETHICON Inc Email: rlibrojo@its.jnj.com Phone: (908) 8086028

Related Public Records

Same Entity

ETHICON INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3023251262 GATT Technologies BV Nijmegen Gelderland, NL
3004903580 Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda SAO JOSE DOS CAMPOS Sao Paulo, BR
3013644499 JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA Guarulhos Sao Paulo, BR
3003702646 ETHICON SARL NEUCHATEL, CH
3014272734 GMED Healthcare BVBA ( a Johnson & Johnson Company) Courcelles Luxembourg, BE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002294946. Last updated year: 2026. Please use registration number 3002294946 when referencing this establishment in official correspondence.
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