Panels › Gastroenterology, Urology › Product code EZL · Class 2
Catheter, Retention Type, Balloon
Regulation 876.5130
4510(k)s in 12 months (131 all time)
2recalls in 12 months (85 all time)
82recalls that name a 510(k)
Top companies in EZL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 1997 | K970716 | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE Opticon Medical, Inc. | EZL |
| Feb 4, 1997 | K964575 | SYMPACATH HYDROGEL COATED FOLEY Rusch Intl. | EZL |
| Aug 30, 1996 | K961697 | OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE Medical Device Intl., Inc. | EZL |
| Apr 10, 1996 | K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE Regulatory & Marketing Services, Inc. | EZL |
| Apr 5, 1996 | K944676 | MRI'S ALL SILICONE FOLEY CATHETER Mri Manufacturing and Research, Inc. | EZL |
| Oct 30, 1995 | K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Jun 29, 1995 | K944007 | EUROPHILIC SLIPPERY COATED FOLEY CATHETER Baxter Healthcare Corp | EZL |
| May 25, 1995 | K951106 | SILICONE FOLEY CATHETER Cook Urological, Inc. | EZL |
| Apr 28, 1995 | K951103 | SILASTIC BRAND FOLEY CATHETER C.R. Bard, Inc. | EZL |
| Mar 21, 1995 | K945806 | SILICATH ALL SILICONE FOLEY CATHETER Unomedical Sdn Bhd, MY | EZL |
| Mar 6, 1995 | K941692 | FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER Rochester Medical Corp. | EZL |
| Dec 6, 1994 | K944382 | ORION ALL SILICONE FOLEY CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Nov 30, 1994 | K944381 | ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE Regulatory & Marketing Services, Inc. | EZL |
| Nov 30, 1994 | K944380 | ORION FOLEY CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Nov 30, 1994 | K944376 | ORION ALL SILICONE ELASTOMER COATED CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Nov 30, 1994 | K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER Medical Technology Development Corp. | EZL |
| Oct 13, 1994 | K934895 | GLASSMAN SILICONE CATHETER Axiom Medical, Inc. | EZL |
| Oct 7, 1994 | K935630 | NORTA Beiersdorf, Inc. | EZL |
| Apr 15, 1994 | K930344 | SILICONE FOLEY CATHETER Cook Urological, Inc. | EZL |
| Mar 17, 1994 | K932809 | FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR Excalibur Engineering Care of Rms, Inc. | EZL |
| Feb 25, 1993 | K911617 | UROTECH CATHETER Urotech U.S.A., Inc. | EZL |
| Nov 23, 1992 | K922821 | YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES Yellow Springs Instrument Co., Inc. | EZL |
| Nov 23, 1992 | K921561 | YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES Ysis, Inc. | EZL |
| Jan 18, 1991 | K905042 | COMFORT SLEEVED ALL SILICONE FOLEY CATHETER Rochester Medical Corp. | EZL |
| Dec 13, 1990 | K903777 | WRP FOLEYCATH Wembley Rubber Products (M) Sdn Bhd, MY | EZL |
| Nov 21, 1990 | K902710 | FOLEY CATHETER Societa Gruppi Elastomeri S.A., ES | EZL |
| Apr 25, 1990 | K894883 | PHYCON ALL SILICONE BALLOON CATHETER Vitaid, Ltd., CA | EZL |
| Mar 13, 1981 | K810691 | CURITY 100% SILICONE IRRIGATION FOLEY The Kendal Co. | EZL |
| Feb 14, 1978 | K780062 | CATHETER/HEMOSTATIC/GERIATRIC Kendall Research Center | EZL |
| Dec 13, 1977 | K772218 | CATHETER, SILICONE COATED Concord Laboratories, Inc. | EZL |
| Oct 18, 1977 | K771860 | FOLHY CATHETER Polysil, Inc. | EZL |
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