Medtronic Bio-Medicus, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Medtronic Bio-Medicus, Inc. makes
Medtronic Bio-Medicus, Inc. manufactures extracorporeal circulation devices, including blood pumps (e.g., the BPX80 BIO-PUMP), cannulas and introducers for vascular access, and blood flow monitoring systems (e.g., the BIO-PROBE Blood Flow Monitoring System). The company also produces oxygen saturation and hematocrit monitoring systems (e.g., MEDSAT and BIOTREND systems) and hand-cranked blood oxygenation devices (e.g., the HandCrank Model 150). Additional offerings include bio-consoles for controlling pump speed and extracorporeal circuits, such as the Model 540-D, 540E, and 550 series.
All listed devices fall under Class II regulatory classification in the U.S. and are authorised via 510(k) premarket notifications through the FDA. The company’s products are registered under the U.S. regulatory system, with no international registries specified. The manufacturer is based in the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Medtronic Bio-Medicus, Inc. have in the registry?
The registry currently lists 13 devices for Medtronic Bio-Medicus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Bio-Medicus, Inc.'s devices?
Among its 13 most recently registered devices, Medtronic Bio-Medicus, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Medtronic Bio-Medicus, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Medtronic Bio-Medicus, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Bio-Medicus, Inc. in the registry?
The most recently registered devices listed for Medtronic Bio-Medicus, Inc. include BPX80 BIO-PUMP (BPX80), MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER, BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) and MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT.