Bio-Dyne, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bio-Dyne, Inc. makes
Bio-Dyne, Inc. manufactures disposable cold therapy packs for wound care, a portable infant respiration and heart rate monitor for clinical use, and pre-moistened instrument wipes designed for medical equipment cleaning and disinfection.
The company’s products are regulated under FDA Class I, Class II, and Class II exempt (U) categories, with relevant devices listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Hemorx Cold Pack Ref K883984
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Biodyne Instrument Wipes Ref K900691
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Dyne, Inc. have in the registry?
The registry currently lists 3 devices for Bio-Dyne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Dyne, Inc.'s devices?
Among its 3 most recently registered devices, Bio-Dyne, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bio-Dyne, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bio-Dyne, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Dyne, Inc. in the registry?
The most recently registered devices listed for Bio-Dyne, Inc. include HEMORX COLD PACK, MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR and BIODYNE INSTRUMENT WIPES.