Hart Enterprises, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1828424
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
What Hart Enterprises, Inc. makes
Hart Enterprises, Inc. manufactures specialized needle-based devices for medical procedures, including automated biopsy modifications, pencil-point spinal needles, breast localization needles, and needle inserts for soft tissue biopsy systems. These products are designed for precision in interventional radiology, orthopedics, and oncology applications.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance database. The manufacturer is based in the United States.
Catalogue
Automated Biopsy Device, Modification Ref K913815
Regimes: 510(k) Registry: 510(k)Pencil Point Spinal Needle Ref K921683
Regimes: 510(k) Registry: 510(k)Breast Localization Needles Ref K881730
Regimes: 510(k) Registry: 510(k)Needle Insert For Soft Tissue Biopsy Device Ref K885149
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1828424
- Address
- 400 APPLEJACK CT., SPARTA, MI, 49345
Frequently asked questions
How many devices does HART ENTERPRISES, INC. have in the registry?
The registry currently lists 4 devices for HART ENTERPRISES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list HART ENTERPRISES, INC.'s devices?
Among its 4 most recently registered devices, HART ENTERPRISES, INC. has devices listed in FDA 510(k) (4 devices).
What risk classes do HART ENTERPRISES, INC.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for HART ENTERPRISES, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from HART ENTERPRISES, INC. in the registry?
The most recently registered devices listed for HART ENTERPRISES, INC. include AUTOMATED BIOPSY DEVICE, MODIFICATION, PENCIL POINT SPINAL NEEDLE, BREAST LOCALIZATION NEEDLES and NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE.