Delmed, Inc.
United StatesFDA applicant, unverified
- Devices
- 27
What Delmed, Inc. makes
Delmed, Inc. manufactures enteral feeding systems, including pump sets with specialized spikes, enteral administration bags (600 mL and 1200 mL), and compatible tubing sets for use with feeding pumps. The company also provides sterile water for inhalation, intravenous administration sets for albumin, and empty transfer/dialysate containers for medical use. Dialysis-related products include a dialysis system with last-bag options and dialysate solutions for continuous arteriovenous hemodiafiltration (C.A.V.H.D.).
The company’s products are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) and Class II (special controls). These products are listed in the U.S. FDA registry, adhering to applicable medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 27 devicesFrequently asked questions
How many devices does Delmed, Inc. have in the registry?
The registry currently lists 27 devices for Delmed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Delmed, Inc.'s devices?
Among its 27 most recently registered devices, Delmed, Inc. has devices listed in FDA 510(k) (27 devices).
What risk classes do Delmed, Inc.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Delmed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Delmed, Inc. in the registry?
The most recently registered devices listed for Delmed, Inc. include ENTERAL PUMP SET W/ENTERA-FLO SPIKE, INTERTECH STERILE WATER FOR INHALATION, DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION and EMPTY TRANSFER BAG.