GBM

Injury

397

Malfunction

1,404

Total

1,801

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 →

• K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact Well Lead Medical Co., Ltd. · 2025-03-05
• K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter Convatec Limited · 2022-06-22
• K211436 — Intermittent Catheter (Not Finalized) Hollister Incorporated · 2022-01-27
• K200820 — SpeediCath Compact Set Coloplast · 2020-11-13
• K192904 — SpeediCath Compact Set Coloplast · 2020-11-02
• K200142 — SpeediCath Soft Coloplast · 2020-07-30
• K200134 — Jimushi Sterile Urethral Catheter for single use Hangzhou Jimushi Meditech Co., Ltd. · 2020-06-01
• K191512 — LotusCatheter (Lotus No Balloon Catheter) Hakki Medical Technologies, Inc. · 2020-05-21
• K192577 — Actreen Hi-Lite Intermittent Urinary Catheters B.Braun Medical, Inc. · 2020-05-07
• K193148 — VaPro Plus Pocket, VaPro Plus Hollister Incorporated · 2019-12-13
• K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter Hangzhou Bever Medical Devices Co., Ltd. · 2019-11-27
• K191633 — Infyna Chic Hollister Incorporated · 2019-07-19
• K190620 — SpeediCath Flex Coude Pro Coloplast · 2019-07-10
• K183335 — Medline Poly-Cath Red Polymer Urethral Catheter Medline Industries, Inc. · 2019-06-12
• K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Teleflexmedical, Inc. · 2019-05-08
• K182511 — SimplCath F&S Medical Solutions, LLC · 2019-03-20
• K183253 — ValPro 2 Plus, VaPro 2 Plus Pocket Hollister Incorporated · 2018-12-18
• K180801 — Actreen Hi-Lite Cath, Actreen Hi-Lite Set B.Braun Medical, Inc. · 2018-11-05
• K180258 — SpeediCath Standard Coloplast · 2018-10-25
• K181206 — GentleCath Glide Intermittent Urinary Catheter Convatec Limited · 2018-08-16
• K180824 — VaPro 2 Intermittent Catheter Hollister Incorporated · 2018-06-22
• K180070 — SpeediCath Flex Coude Pro Coloplast · 2018-02-02
• K172278 — Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated · 2017-11-22
• K163179 — Onli Intermittent Catheter Hollister Incorporated · 2017-01-26
• K161672 — SpeediCath Flex Coude Coloplast Corp. · 2016-09-29
• K160795 — United Urologics Intermittent Catheter Robling Medical · 2016-06-16
• K151772 — Actreen Mini Intermittent Urinary Catheters B.Braun Medical, Inc. · 2016-02-09
• K152268 — VAPRO PLUS POCKET Intermittent Catheter Hollister Incorporated · 2015-09-09
• K150935 — SpeediCath Compact Eve Coloplast A/S · 2015-07-02
• K142767 — ThinkMed Intermittent Catheter with/without Hydrophilic Coating Thinkmed Medical Technology Co., Ltd. · 2015-02-03
• K143182 — Speedicath Compact Male Coloplast A/S · 2015-01-20
• K143594 — VaPro Pocket Hollister Incorporated · 2015-01-09
• K141642 — VAPRO INTERMITTENT CATHETER Hollister Incorporated · 2014-08-22
• K121457 — SPEEDICATH COMPACT SET (12 FR) Coloplast Corp. · 2012-10-02
• K121458 — SPEEDICATH COMPACT SET (12/18 FR) Coloplast A/S · 2012-10-01
• K111405 — BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, Hangzhou Bever Medical Devices Co., Ltd. · 2012-02-13
• K110862 — VAPRO PLUS INTERMITTENT CATHETER Hollister Incorporated · 2011-04-26
• K101900 — HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH Hakki Medical Technologies, Inc. · 2011-02-07
• K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, Hollister, Inc. · 2009-08-20
• K072808 — SPEEDICATH COMPACT Coloplast Corp. · 2007-11-09
• K063795 — GUARDIANCATHETER-URINARY DRAINAGE CATHETER Marian Medical, Inc. · 2007-03-05
• K060268 — PEDIATRIC URINARY CATHETER Clay Kennard · 2006-02-24
• K050874 — ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER Astra Tech, Inc. · 2005-05-05
• K043241 — LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER Astra Tech, Inc. · 2004-12-23
• K031409 — URINARY CATHETERS Promedic, Inc. · 2003-06-17
• K021938 — VITALCARE URETHRAL CATHETER Vitalcare, Inc. · 2003-04-22
• K023254 — SPEEDICATH Coloplast Corp. · 2003-01-27
• K020714 — RUSCH FLONEIL; FLOCATH INTROGEL Rusch Intl. · 2002-07-01
• K012374 — MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER Astra Tech, Inc. · 2001-08-23
• K011552 — UROLOGICAL CATHETER Apogee Medical, Inc. · 2001-07-18
• K993651 — O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER Sc Hennig Enterprises Europe Srl · 1999-12-23
• K992137 — UROLOGICAL CATHETER Apogee, Inc. · 1999-09-03
• K973120 — READYCATH CATHETER Medical Technologies of Georgia · 1998-02-25
• K970704 — PERSONAL CATHETER Rochester Medical Corp. · 1997-03-13
• K965067 — DILATION CATHETER, BALLOON Boston Scientific Corp · 1997-01-28
• K961361 — ASTA-CATH A+ Products · 1996-10-31
• K952924 — ADI CATHETER WITH VALVE Asia Dynamics, Inc. · 1995-08-18
• K943851 — ALL SILICONE INTERMITTENT CATHETER Rochester Medical Corp. · 1995-01-31
• K941672 — URI-CATH CATHETER Gesco Intl., Inc. · 1994-05-16
• K926369 — WALTHER CATHETERS, MALE, FEMALE Thomasville Medical Assoc. · 1993-05-21
• K914905 — ENTRAC(TM) URETHRAL MEASURING CATHETER American Medical Systems, Inc. · 1992-03-20
• K910876 — AUTOCATH(TM) SET Cook Urological, Inc. · 1991-05-28
• K901441 — ALBERT MORTON UROLOGICAL CATHETER Transinternational Marketing Group · 1990-06-22
• K901336 — ASI HEMOSTASIS CATHETER Advanced Surgical Intervention, Inc. · 1990-06-20
• K892442 — KENDALL CURITY URETHRAL CATHETERS The Kendal Co. · 1989-06-23
• K881667 — KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH The Kendal Co. · 1988-08-12
• K871999 — MMG URO-SELF CATHETER Medical Marketing Group · 1987-08-25
• K830840 — OPEN ENDED URETERAL CATHETER Van-Tec, Inc. · 1983-04-06
• K760093 — CATHETER, SILICONE FOLEY (BARDEX) C.R. Bard, Inc. · 1976-08-23
• K760253 — TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG C.R. Bard, Inc. · 1976-08-23
• K760254 — TRAY, FOLEY CATHETER C.R. Bard, Inc. · 1976-08-23