Johnson & Johnson Medical, Div. of Ethicon, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Johnson & Johnson Medical, Div. of Ethicon, Inc. makes
The company manufactures single-use surgical gloves, including latex-free options, and barrier surgical gowns for sterile procedures. It also produces intravenous (IV) catheters, including modified versions of JELCO, CATHLON, and OPTIVA lines, designed for vascular access. Additionally, it supplies hydrocolloid dressings, such as Tielle and Tielle Plus, for wound care and skin protection.
These products are regulated under FDA classifications, including Class I, Class II, and unclassified (U) devices, with many authorised via the 510(k) pathway. The company’s devices are listed in the FDA’s 510(k) database, and the portfolio is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Barrier Surgical Gowns Ref K990395
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Modification To Tielle Hydropolmer Dressing Ref K983394
Regimes: 510(k) Registry: 510(k)Tielle Plus Hydropolymer Adhesive Dressing Ref K983234
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Johnson & Johnson Medical, Div. of Ethicon, Inc. have in the registry?
The registry currently lists 5 devices for Johnson & Johnson Medical, Div. of Ethicon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Johnson & Johnson Medical, Div. of Ethicon, Inc.'s devices?
Among its 5 most recently registered devices, Johnson & Johnson Medical, Div. of Ethicon, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Johnson & Johnson Medical, Div. of Ethicon, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Johnson & Johnson Medical, Div. of Ethicon, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Johnson & Johnson Medical, Div. of Ethicon, Inc. in the registry?
The most recently registered devices listed for Johnson & Johnson Medical, Div. of Ethicon, Inc. include NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES, BARRIER SURGICAL GOWNS, MODIFICATION OF JELCO*, JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT and MODIFICATION TO TIELLE HYDROPOLMER DRESSING.