Panels › Gastroenterology, Urology › Product code EZN · Class 2

Dilator, Catheter, Ureteral

Regulation 876.5470

0510(k)s in 12 months (56 all time)

0recalls in 12 months (14 all time)

14recalls that name a 510(k)

Top companies in EZN

Company	510(k)s	Recalls
Boston Scientific Corp	9	10
Cook Urological, Inc.	5	2
American Edwards Laboratories	5	0
Cook Incorporated	4	0
Van-Tec, Inc.	4	0
American Medical Systems, Inc.	3	0
C.R. Bard, Inc.	3	0
Meadox Medicals, Div. Boston Scientific Corp.	3	0
Meadox Surgimed, Inc.	3	0
Coloplast Corp.	2	0

Decided	510(k)	Device and applicant	Code
Oct 2, 1984	K842639	AMER. EDWARDS LAB DIAFLEX URETERAL DILA American Edwards Laboratories	EZN
Oct 2, 1984	K842632	DILATOR/SHEATH SET American Edwards Laboratories	EZN
Oct 2, 1984	K842206	DIAFLEX NEPHROSTOMY BALLOON DILATOR American Edwards Laboratories	EZN
Aug 3, 1984	K841940	VAN-TEC URETERAL DILATION BALLOON CATH Van-Tec, Inc.	EZN
Oct 14, 1983	K832808	URETERAL DILATION SET Van-Tec, Inc.	EZN
Dec 18, 1981	K813278	VPI URETERAL DILATATION BALLON CATHETER Vance Products, Inc.	EZN

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