Smith & Nephew United, Inc.
United StatesFDA applicant, unverified
- Devices
- 34
What Smith & Nephew United, Inc. makes
The company manufactures wound care products including adhesive dressings (e.g., OPSITE WOUND, ALLEVYN ADHESIVE, HYPAFIX RETENTION SHEET), foam and hydrocolloid dressings (e.g., CAVI-CARE CONFORMING FOAM, ALLEVYN TRACHEOSTOMY DRESSING), wound gels (e.g., SOLOSITE DERMAL WOUND GEL, INTRASITE GEL), and wound management systems (e.g., TENS PREP). It also produces medical thermometers (GLASS MERCURY FILLED THERMOMETERS) and an intravenous solution (PRIMAPORE I.V.). Strapping products (STRAPPAL) are included in the portfolio.
These devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with many authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 34 devicesFrequently asked questions
How many devices does Smith & Nephew United, Inc. have in the registry?
The registry currently lists 34 devices for Smith & Nephew United, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith & Nephew United, Inc.'s devices?
Among its 34 most recently registered devices, Smith & Nephew United, Inc. has devices listed in FDA 510(k) (34 devices).
What risk classes do Smith & Nephew United, Inc.'s devices fall under?
Among its 34 most recently registered devices, the classes recorded for Smith & Nephew United, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smith & Nephew United, Inc. in the registry?
The most recently registered devices listed for Smith & Nephew United, Inc. include OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM), ALLEVYN DRESSING CLAIMS CHANGE, SOLOSITE DERMAL WOUND GEL and GLASS MERCURY FILLED THERMOMETERS.