Panels › Gastroenterology, Urology › Product code EZD · Class 2
Catheter, Straight
Regulation 876.5130
11510(k)s in 12 months (87 all time)
0recalls in 12 months (13 all time)
12recalls that name a 510(k)
Top companies in EZD
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 5 | 7 |
| Coloplast | 12 | 0 |
| Convatec | 6 | 0 |
| Cure Medical, LLC | 3 | 2 |
| Hollister Incorporated | 5 | 0 |
| Compactcath, Inc. | 3 | 0 |
| Well Lead Medical Co., Ltd. | 3 | 0 |
| Wellspect AB | 3 | 0 |
| Wellspect HealthCare (Division of DENTSPLY IH AB) | 0 | 3 |
| Adapta Medical, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 22, 2014 | K140945 | COMPACTCATH INTERMITTENT URINARY CATHETER Compactcath, Inc. | EZD |
| Apr 4, 2014 | K133470 | BARD RITECATH INTERMITTENT CATHETER C.R. Bard, Inc. | EZD |
| Feb 24, 2014 | K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER Well Lead Medical Co., Ltd. | EZD |
| Dec 23, 2013 | K132500 | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED Cure Medical, LLC | EZD |
| Oct 11, 2013 | K132619 | CLASSIC INTERMITTENT CATHETER Flexicare Medical, Ltd., GB | EZD |
| May 14, 2013 | K122785 | HYDROSIL; MAGIC; PERSONAL CATHETER Rochester Medical Corp. | EZD |
| Feb 28, 2013 | K123751 | LOFRIC SENSE Wellspect Healthcare | EZD |
| Oct 31, 2012 | K122078 | LOFRIC PRIMO, LOFRIC HYDRO-KIT Astra Tech, Inc. | EZD |
| Apr 17, 2012 | K113424 | LOFRIC SINGLE USE URINARY CATHETER Astra Tech AB | EZD |
| Aug 26, 2011 | K112137 | COMFORTGLIDE INTERMITENT CATHETER C.R. Bard, Inc. | EZD |
| Aug 1, 2011 | K110653 | CURE CATHETER Cure Medical, LLC | EZD |
| Jun 7, 2011 | K103086 | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC Dynarex Corporation | EZD |
| Jan 7, 2011 | K103043 | COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH Adapta Medical, Inc. | EZD |
| Jul 2, 2010 | K100302 | MEDLINE PVC URETHRAL CATHETER Medline Industries, Inc. | EZD |
| May 26, 2010 | K100878 | SELF CATH CATHETER Coloplast Manufacturing Us, LLC | EZD |
| Aug 21, 2009 | K091306 | AMSURE PVC INTERMITTENT CATHETER Amsino International, Inc. | EZD |
| Aug 12, 2009 | K090576 | FOOTPRINT URINARY DRAINAGE CATHETER Footprint Medical | EZD |
| May 13, 2008 | K080007 | GRADUATED ADAPTER WITH CLAVE Icu Medical, Inc. | EZD |
| Dec 19, 2007 | K072997 | NEOMED URINARY CATHETER Neomed, Inc. | EZD |
| Sep 13, 2007 | K072539 | CURE CATHETER Cure Medical, LLC | EZD |
| Mar 9, 2007 | K061766 | EXPRESSWAY INTERMITTENT CATHETER Percutaneous Systems, Incorporated | EZD |
| Feb 22, 2007 | K062444 | HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. | EZD |
| Oct 11, 2005 | K052440 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER Mentor Corporation | EZD |
| Jun 3, 2005 | K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER Mentor Corp. | EZD |
| Nov 5, 2004 | K041464 | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER Busse Hospital Disposables | EZD |
| May 20, 2004 | K040519 | SLIP UROLOGY CATHETER Percutaneous Systems, Inc. | EZD |
| Apr 10, 2003 | K023872 | VITALCARE URETHRAL CATHETER RED RUBBER Vitalcare, Inc. | EZD |
| Mar 10, 2003 | K030538 | AMERICAN CATHETER, MODEL W3 Catheter, LLC | EZD |
| Dec 10, 1999 | K993226 | MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 Memcath Technologies, LLC | EZD |
| Nov 7, 1997 | K973546 | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health | EZD |
| Nov 6, 1997 | K973070 | CONVEEN EASICATH SET Coloplast Corp. | EZD |
| Dec 6, 1994 | K944383 | ORION RED URETHRAL CATHETER Regulatory & Marketing Services, Inc. | EZD |
| Oct 13, 1994 | K944782 | CATCO UROLOGICAL CATHETER Catco Medical, Inc. | EZD |
| Feb 18, 1994 | K923848 | GOOSEN SELF-LUBRICATING CATHETER Goosen Enterprises, Inc. | EZD |
| Feb 14, 1994 | K931048 | 4-SURE NELATON CATHETER Boston Pacific Medical, Inc. | EZD |
| Feb 14, 1994 | K931047 | 4-SURE FEMALE CATHETER Boston Pacific Medical, Inc. | EZD |
| Apr 13, 1978 | K780411 | TAYLOR CATHETER HOLDER Taylor Catheter Holder Mfg. | EZD |
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