EZN

Death

3

Injury

127

Total

130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter Urotronic, Inc. · 2025-05-22
• K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter Allwin Medical Devices, Inc. · 2023-05-05
• K201007 — In-Ka Ureteral Balloon Dilatation Catheter Coloplast Corp. · 2020-06-11
• K190612 — EQUINOX Balloon Dilatation Catheter Dornier Medtech America, Inc. · 2019-12-06
• K173654 — Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated · 2018-07-17
• K180756 — Safety Wire Guide Introducer Cook Incorporated · 2018-05-24
• K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set Cook Incorporated · 2018-05-02
• K172588 — Balloon Catheter and Balloon Ureteral Dilator Set Cook Incorporated · 2018-04-19
• K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp. · 2017-08-17
• K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER Olympus Surgical Technologies America · 2013-10-21
• K130804 — UROMAX ULTRA BALLOON DILATATION CATHETER Boston Scientific Corporation · 2013-05-22
• K061009 — PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS Onset Medical Corporation · 2006-05-02
• K050875 — U-BALLOON DILATION CATHETER C.R. Bard, Inc. · 2005-05-26
• K043254 — PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH Onset Medical Corporation · 2005-02-10
• K040127 — COOK URETERAL BALLOON DILATION CATHETER SET Cook Urological, Inc. · 2004-04-06
• K030662 — PATHWAY ACCESS SHEATH CATHETER Vertelink Corporation · 2003-09-03
• K993840 — BARD UROFORCE BALLOON DILATION CATHETER C.R. Bard, Inc. · 2000-01-31
• K990072 — BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C Cook Urological, Inc. · 1999-03-25
• K980795 — UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp · 1998-04-22
• K970041 — ASCEND BALLOON DAILATION CATHETER Cook Urological, Inc. · 1997-03-19
• K962921 — BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER C.R. Bard, Inc. · 1996-10-09
• K953691 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. · 1995-10-16
• K953597 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. · 1995-10-07
• K953004 — DILATATION CATHETER, BALLOON Boston Scientific Corp · 1995-09-13
• K945576 — MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) Meadox Medicals, Div. Boston Scientific Corp. · 1995-01-24
• K941853 — PASSPORT Boston Scientific Corp · 1994-09-12
• K942578 — ENTRAC URETERAL BALLOON DILATATION CATHETERS American Medical Systems, Inc. · 1994-08-19
• K940542 — NAMIC ARIA(TM) INFLATION DEVICE American Medical Systems, Inc. · 1994-04-18
• K935379 — UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp · 1994-02-14
• K933011 — MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER Boston Scientific Corp · 1994-02-01
• K921839 — ENTRAC URETERAL BALLOON DILATION CATHETERS American Medical Systems, Inc. · 1992-10-28
• K920946 — UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp · 1992-07-01
• K915751 — URETEROMAT 4400 F.M. Wiest USA, Inc. · 1992-04-24
• K915392 — ACCENT DG BALLOON URTERAL DILATOR SET, 10CM Cook Urological, Inc. · 1992-03-18
• K914617 — CATHETER, URETERAL DILATOR Boston Scientific Corp · 1991-12-20
• K912331 — URS-HYDRO-DILATOR MODEL NUMBER 2164.00 Richard Wolf Medical Instruments Corp. · 1991-10-30
• K905375 — ACCENT DG BALLOON URETERAL DILATOR SET Cook Urological, Inc. · 1991-04-12
• K905181 — NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY Meadox Surgimed, Inc. · 1991-03-06
• K904983 — MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY Meadox Surgimed, Inc. · 1991-01-30
• K903813 — URETERAL BALLOON DILATATION CATHETER Boston Scientific Corp · 1990-11-07
• K896448 — BALLOON DILATION CATHETER Cook Ob/Gyn · 1990-03-07
• K894925 — AMCATH URETERAL DILATORS MODELS 7100,7110,7120 Intec Medical, Inc. · 1989-12-13
• K884711 — URETHRAL AND URETERAL BALLOON DILATATORS Primrose Medical, Inc. · 1989-09-29
• K873178 — URETERAL BULB DILATORS Penn Medical Devices, Inc. · 1987-09-30
• K870697 — VAN-TEC ONE STEP URETERAL DILATATION CATHETER Van-Tec, Inc. · 1987-03-10
• K852324 — URETERAL DILATOR American Edwards Laboratories · 1985-08-21
• K852793 — URETERAL DILATOR/SHEATH SET American Edwards Laboratories · 1985-08-09
• K851463 — OLBERT CATHETER SYS FOR URETERAL DILATION Meadox Surgimed, Inc. · 1985-05-23
• K851144 — URETERAL DILATION SET Van-Tec, Inc. · 1985-04-09
• K850355 — MENTOR PERCUTANEOUS RENAL DILATOR SET Mentor Corp. · 1985-03-12
• K842206 — DIAFLEX NEPHROSTOMY BALLOON DILATOR American Edwards Laboratories · 1984-10-02
• K842632 — DILATOR/SHEATH SET American Edwards Laboratories · 1984-10-02
• K842639 — AMER. EDWARDS LAB DIAFLEX URETERAL DILA American Edwards Laboratories · 1984-10-02
• K841940 — VAN-TEC URETERAL DILATION BALLOON CATH Van-Tec, Inc. · 1984-08-03
• K832808 — URETERAL DILATION SET Van-Tec, Inc. · 1983-10-14
• K813278 — VPI URETERAL DILATATION BALLON CATHETER Vance Products, Inc. · 1981-12-18