Denver Biomedicals, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Denver Biomedicals, Inc. makes
Denver Biomedicals, Inc. manufactures medical devices for fluid drainage and management, including corneal protectors for eye care, peritoneal-venous and pleural effusion shunts for ascites and pleural fluid, and related drainage kits with vacuum bottles and catheters. Their portfolio also includes ascites shunts with single- and double-valve configurations, as well as tunneling tools for implant procedures.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their authorised status under US medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Denver Biomedicals, Inc. have in the registry?
The registry currently lists 15 devices for Denver Biomedicals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denver Biomedicals, Inc.'s devices?
Among its 15 most recently registered devices, Denver Biomedicals, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Denver Biomedicals, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Denver Biomedicals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Denver Biomedicals, Inc. in the registry?
The most recently registered devices listed for Denver Biomedicals, Inc. include PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS, CROUCH CORNEAL PROTECTOR, DENVER PERITONEO-VENOUS SHUNT (DP-VS) and DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER.