Company ยท US
Cure Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2013. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2013 | K132500 | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED Cure Medical, LLC | EZD |
| Aug 1, 2011 | K110653 | CURE CATHETER Cure Medical, LLC | EZD |
| Jun 11, 2008 | K080881 | CURE CATHETER CLOSED SYSTEM Cure Medical, LLC | KOD |
| Sep 13, 2007 | K072539 | CURE CATHETER Cure Medical, LLC | EZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Cure Medical LLC Pediatric, 10Fr, Intermittent Urinary Catheters
Model: P10
Pouch Label UPC (P10) *+M405P100C*
Intermediate Box Label UPC (P10) *+M405P103F*
Carton Label UPC (P10) *+M405P105H*
The product is distribu Terminated |
EZD | K110653 |
| Oct 2, 2012 | Cure Medical LLC Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialy Terminated |
EZD | K072539 |