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Cure Medical LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0496-2015Class IIPediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* IntNovember 11, 2014
Z-0004-2013Class IIMale, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individuallySeptember 19, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETEDecember 23, 2013
K110653CURE CATHETERAugust 1, 2011
K080881CURE CATHETER CLOSED SYSTEMJune 11, 2008
K072539CURE CATHETERSeptember 13, 2007