Healthtek, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Healthtek, Inc. makes
Healthtek, Inc. manufactures medical accessories and infusion devices, including empty solution transfer containers with detachable legs, transfer aids for fluid handling, and aqueous solution filters. Their portfolio also covers adhesive dressings (ADFUSE and ADCOMP variants) and specialized medical tools like the SNAPPER, STATLOCK, and retrobulbar needles. Additional products include high-pressure infusion systems (ADCOMP 4000 HP) and sterile components for fluid administration.
The company’s devices are regulated under FDA 510(k) clearance, spanning Class I and Class II classifications. Products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Healthtek, Inc. is based in the United States.
Catalogue
Empty Solution Transfer Container W/ Detach Leg Ref K923448
Regimes: 510(k) Registry: 510(k)Transfer-Aid(Tm) Ref K913985
Regimes: 510(k) Registry: 510(k)Adfuse(Tm) Ref K881590
Regimes: 510(k) Registry: 510(k)Adcomp Ref K860610
Regimes: 510(k) Registry: 510(k)Adcomp 4000 Hp System Ref K874495
Regimes: 510(k) Registry: 510(k)Snapper Ref K913608
Regimes: 510(k) Registry: 510(k)Statlock Ref K854008
Regimes: 510(k) Registry: 510(k)Retrobulbar Needle Ref K873848
Regimes: 510(k) Registry: 510(k)Fast Flow Xx (Aqueous Solution Filter) Ref K860372
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthtek, Inc. have in the registry?
The registry currently lists 9 devices for Healthtek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthtek, Inc.'s devices?
Among its 9 most recently registered devices, Healthtek, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Healthtek, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Healthtek, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthtek, Inc. in the registry?
The most recently registered devices listed for Healthtek, Inc. include EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG, TRANSFER-AID(TM), ADFUSE(TM) and ADCOMP.