# Anexa Biomedical, Inc.

- Location (FDA's records): Zephyrhills, FL
- FDA decisions: 2 (2016–2017): 2 510(k) clearances
- Product codes: FRO (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (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 whose devices it cites most
- Nurse Assist, Inc.: 2 (https://510kreport.com/company/nurse-assist)
- Strukmyer Medical, LLC: 1 (https://510kreport.com/company/strukmyer-medical)

## Firms that cite its devices most
- Amsino International, Inc.: 1 (https://510kreport.com/company/amsino-international)

## Its most-cited devices
- K172486: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (2017), cited by 1

## Recent decisions
- K172486: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (Sep 21, 2017)
- K161658: Anexa Wound Flush, Sterile Water & Sterile Normal Saline (Sep 14, 2016)

Source page: https://510kreport.com/company/anexa-biomedical