Data / Medical devices / Germany / Johnson & Johnson MEDICAL GmbH
Johnson & Johnson MEDICAL GmbH: FDA-registered device maker in NORDERSTEDT Schleswig-Holstein, Germany, 13 510(k) clearances
Johnson & Johnson MEDICAL GmbH is registered with the FDA (registration 3002294946) in NORDERSTEDT Schleswig-Holstein, Germany. It lists 9 device types. The FDA files 13 510(k) clearances under its listings, the newest dated June 27, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002294946
- Address
- Robert-Koch-Strasse 1, NORDERSTEDT Schleswig-Holstein, Germany, 22851
- Owner or operator
- ETHICON INC. (2210968)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 31, 1998
- Registered through
- 2026
- Brand names listed
- Artisyn Y-Shaped Mesh, Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture, Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture, Codman Ethisorb DURA PATCH, Dura Patch, ECHELON ENDOPATH Staple Line Reinforcement, EES - ECHELON ENDOPATH Staple Line Reinforcement, ENDOPATH SELF-RIGH and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Manufacturer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | 2 | Contract manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | OTO | 2 | Manufacturer | accessdata.fda.gov |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| September 28, 2018 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 2, 2018 | K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | FTL | Substantially Equivalent | ETHICON, Inc. | 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 |
| February 28, 2014 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 11, 2012 | K113205 | ARTISYN Y-SHAPED MESH | OTO | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 17, 2010 | K092590 | PDS PLATES | NHB | Substantially Equivalent | ETHICON, 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 |
| May 25, 2006 | K060713 | PROCEED SURGICAL MESH | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 22, 2003 | K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- All makers of Clamp, Surgical, General & Plastic Surgery
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- All makers of Mesh, Surgical, Absorbable, Staple Line Reinforcement
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Surgical, Absorbable, Polydioxanone
Updated June 27, 2019. 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.