Molnlycke Health Care US, LLC
United StatesFDA applicant, unverified
- Devices
- 28
What Molnlycke Health Care US, LLC makes
The company manufactures wound care dressings, including gauze and abdominal dressing kits, as well as various undergloves and surgical gloves designed for medical professionals. These products include indicator undergloves, low-dermatitis-potential gloves, and specialized surgical gloves with non-pyrogenic claims. Additional items include active self-warming blankets and wound care dressings with antimicrobial properties, such as Exufiber Ag+.
The portfolio includes Class I, Class II, and unclassified (U) devices, all of which are subject to FDA 510(k) clearance requirements. These products are listed under the FDA’s regulatory framework, and the company operates from the United States.
Catalogue
Search and filter all 28 devicesFrequently asked questions
How many devices does Molnlycke Health Care Us, LLC have in the registry?
The registry currently lists 28 devices for Molnlycke Health Care Us, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Molnlycke Health Care Us, LLC's devices?
Among its 28 most recently registered devices, Molnlycke Health Care Us, LLC has devices listed in FDA 510(k) (28 devices).
What risk classes do Molnlycke Health Care Us, LLC's devices fall under?
Among its 28 most recently registered devices, the classes recorded for Molnlycke Health Care Us, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Molnlycke Health Care Us, LLC in the registry?
The most recently registered devices listed for Molnlycke Health Care Us, LLC include Avance Gauze Dressing Kits, Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro, BIOGEL ORTHOPOR BROWN SURGICAL GLOVE and Exufiber Ag+.