Device type
Catheter, Retention Type, Balloon
Product code EZL · Class II · 21 CFR 876.5130 · Gastroenterology, Urology
Recent 510(k)s
Oct 6, 2026
K261141
OpenFlo Urinary Catheter
Urolution Medical, Inc.
- EZL
- Class II
Sep 4, 2026
K260756
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Sentinel Medical Technologies,
- EZL
- Class II
Recent recalls
Sep 16, 2026
Z-3115-2026
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 108…
C.R. Bard Inc
- EZL
- Class II
- Ongoing