# Promedical, Ltd.

- Location (FDA's records): Wyckoff, NJ
- FDA decisions: 5 (1994–1995): 5 510(k) clearances
- Product codes: FCG (3), LWE (1), GDF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- H.S. Hospital Service S.R.L.: 1 (https://510kreport.com/company/hs-hospital-service)
- Gallini Intl., Inc.: 1 (https://510kreport.com/company/gallini-intl)
- Gallini S.R.L.: 1 (https://510kreport.com/company/gallini)
- H.S. Hospital Services S.P.A.: 1 (https://510kreport.com/company/hs-hospital-services)

## Its most-cited devices
- K951598: Pro-B Biopsy Needle (1995), cited by 3
- K952350: Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan) (1995), cited by 1

## Recent decisions
- K954596: Pro-B Core-Rect Coaxial Biopsy System (Oct 7, 1995)
- K952350: Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan) (Jul 17, 1995)
- K951598: Pro-B Biopsy Needle (Apr 21, 1995)
- K944944: Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy Needle (Dec 21, 1994)
- K944942: Breast Lesion Localization Needle (Nov 4, 1994)

Source page: https://510kreport.com/company/promedical