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

Catheter, Ureteral, Gastro-Urology

Regulation 876.5130

0510(k)s in 12 months (28 all time)
2recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in EYB

Decided510(k)Device and applicantCode
Apr 23, 2020K192183RocaTub Ureteral Catheter
Promepal Sam, MC
EYB
Sep 18, 2019K191187Dornier MINNOW Ureteral Catheter
Dornier Medtech America, Inc.
EYB
Aug 5, 2019K183323UPJ Occlusion Balloon Catheter
Cook Incorporated
EYB
Jun 17, 2019K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
Cook Incorporated
EYB
Oct 4, 2018K182122Ureteric Catheters
Coloplast Corp.
EYB
Sep 14, 2018K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
Cook Incorporated
EYB
Dec 21, 2017K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
Coloplast Corp.
EYB
Jan 8, 2014K133750OCCLUDER OCCLUSION BALLOON CATHETER
Boston Scientific Corporation
EYB
Jan 21, 2010K092250MEDLINE RED RUBBER URETHRAL CATHETER
Medline Industries, Inc.
EYB
Mar 3, 2009K083788ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
Endooptiks, Inc.
EYB
Mar 3, 2005K043581DUAL LUMEN CATHETER
Acmi Corporation
EYB
Feb 4, 2004K030293AMSURE RED RUBBER URETHRAL CATHETER
Amsino International, Inc.
EYB
Nov 26, 2003K033368FOSSA URETERAL OPEN LUMEN STENT
Fossa Medical, Inc.
EYB
Nov 14, 2003K032521BARD DUAL LUMEN URETERAL CATHETER
C.R. Bard, Inc.
EYB
Oct 17, 2002K021856PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
Porges S.A., FR
EYB
May 22, 2002K020577APPLIED URETERAL CATHETER
Applied Medical Resources Corp.
EYB
Feb 7, 1997K964899KENDALL CURITY URETERAL CATHETER
Kendall Healthcare Products Co. Div.Of Tyco Health
EYB
Jun 11, 1996K962004AQ HYDROPHILIC UROLOGICAL CATHETERS
Cook Urological, Inc.
EYB
Apr 27, 1995K950300BARD FLEXIBLE TIP URETERAL CATHETER
C.R. Bard, Inc.
EYB
Jun 13, 1994K941011ACU-SIZER(TM)
Applied Medical Resources
EYB
Apr 18, 1994K941012LOW PRESSURE TAMPONADE BALLOON CATHETER
Applied Medical Resources
EYB
Apr 18, 1994K941010ACUCISE GUIDEWIRE EXCHANGE SHEATH
Applied Medical Resources
EYB
Jan 3, 1994K933020MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
Boston Scientific Corp
EYB
Dec 7, 1993K923729URETERAL CATHETER
Cook Urological, Inc.
EYB
Jul 16, 1993K930483URETERAL CATHETER
Surgitek
EYB
Feb 26, 1993K921838ACUCISE URETERAL CUTTING CATHETER
Applied Urology, Inc.
EYB
Nov 19, 1991K914358ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP
Hobbs Medical, Inc.
EYB
Aug 9, 1988K882130FOLEY-TEMP(TM)
Mallinckroot, Inc.
EYB

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