Benlan, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0595-2016Class IIMED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with December 11, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K131183MED-RX ORAL/ENTERAL SYRINGEJune 3, 2014
K120375MED-RX PATIENT DELIVERY SETJune 28, 2012
K112799MED-RX EXTENSION SET WITH T-CONNECTORDecember 23, 2011
K100700MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESDecember 13, 2010
K102073MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TSNovember 8, 2010
K010607MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001November 28, 2001
K990777MED-RX EXTENSION SETSAugust 25, 1999