Promedical, Ltd.
Country not established
- Devices
- 5
What Promedical, Ltd. makes
Promedical, Ltd. manufactures biopsy needles and systems for medical imaging-guided procedures, including breast lesion localization needles, coaxial biopsy systems, and various biopsy needles (e.g., Chiba, Franseen, Jamshidi, Illinois). Their products are designed for core and fine-needle aspiration biopsies, as well as spinal and soft-tissue interventions.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. Products are listed under U.S. jurisdiction, adhering to applicable medical device regulations.
Catalogue
Breast Lesion Localization Needle Ref K944942
Regimes: 510(k) Registry: 510(k)Pro-B Core-Rect Coaxial Biopsy System Ref K954596
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Pro-B Biopsy Needle Ref K951598
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Promedical, Ltd. have in the registry?
The registry currently lists 5 devices for Promedical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Promedical, Ltd.'s devices?
Among its 5 most recently registered devices, Promedical, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Promedical, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Promedical, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Promedical, Ltd. in the registry?
The most recently registered devices listed for Promedical, Ltd. include BREAST LESION LOCALIZATION NEEDLE, PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM, CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE and JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN).