Bio-Plexus, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Bio-Plexus, Inc. makes
Bio-Plexus, Inc. manufactures medical devices for safe needle handling and blood collection, including winged infusion sets, blood collection needles, needle holders, and disposal containers designed to reduce sharps injuries and improve procedural safety.
The company’s portfolio consists of Class II devices authorised via the FDA’s 510(k) pathway and is based in the United States.
Catalogue
Punctur-Guard Winged Set Ref K961251
Regimes: 510(k) Registry: 510(k)Punctur-Guard(Tm) Blood Collection Needle Ref K895024
Regimes: 510(k) Registry: 510(k)Biosil Medical Grade Silicone Sheeting Ref K932176
Regimes: 510(k) Registry: 510(k)Medical Grade Silicone Block Ref K952732
Regimes: 510(k) Registry: 510(k)Bio-Plexus Drop-It Needle Holder Ref K963748
Regimes: 510(k) Registry: 510(k)Punctur-Guard Revolution Holder, Model 4750 Ref K992091
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Bio-Plexus Needle Disposal Container Ref K960933
Regimes: 510(k) Registry: 510(k)Punctur-Guard Winged Set For Blood Collection Ref K003827
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Plexus, Inc. have in the registry?
The registry currently lists 9 devices for Bio-Plexus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Plexus, Inc.'s devices?
Among its 9 most recently registered devices, Bio-Plexus, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Bio-Plexus, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Bio-Plexus, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Plexus, Inc. in the registry?
The most recently registered devices listed for Bio-Plexus, Inc. include PUNCTUR-GUARD WINGED SET, PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE, BIOSIL MEDICAL GRADE SILICONE SHEETING and MEDICAL GRADE SILICONE BLOCK.