Product code GBM— Gastroenterology, Urology

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 CompactWell Lead Medical Co., Ltd.·2025-03-05
• K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited·2022-06-22
• K211436 — Intermittent Catheter (Not Finalized)Hollister Incorporated·2022-01-27
• K200820 — SpeediCath Compact SetColoplast·2020-11-13
• K192904 — SpeediCath Compact SetColoplast·2020-11-02
• K200142 — SpeediCath SoftColoplast·2020-07-30
• K200134 — Jimushi Sterile Urethral Catheter for single useHangzhou 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 CathetersB.Braun Medical, Inc.·2020-05-07
• K193148 — VaPro Plus Pocket, VaPro PlusHollister 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 CatheterHangzhou Bever Medical Devices Co., Ltd.·2019-11-27
• K191633 — Infyna ChicHollister Incorporated·2019-07-19
• K190620 — SpeediCath Flex Coude ProColoplast·2019-07-10
• K183335 — Medline Poly-Cath Red Polymer Urethral CatheterMedline Industries, Inc.·2019-06-12
• K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent CatheterTeleflexmedical, Inc.·2019-05-08
• K182511 — SimplCathF&S Medical Solutions, LLC·2019-03-20
• K183253 — ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated·2018-12-18
• K180801 — Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.·2018-11-05
• K180258 — SpeediCath StandardColoplast·2018-10-25
• K181206 — GentleCath Glide Intermittent Urinary CatheterConvatec Limited·2018-08-16
• K180824 — VaPro 2 Intermittent CatheterHollister Incorporated·2018-06-22
• K180070 — SpeediCath Flex Coude ProColoplast·2018-02-02
• K172278 — Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated·2017-11-22
• K163179 — Onli Intermittent CatheterHollister Incorporated·2017-01-26
• K161672 — SpeediCath Flex CoudeColoplast Corp.·2016-09-29
• K160795 — United Urologics Intermittent CatheterRobling Medical·2016-06-16
• K151772 — Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc.·2016-02-09
• K152268 — VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated·2015-09-09
• K150935 — SpeediCath Compact EveColoplast A/S·2015-07-02
• K142767 — ThinkMed Intermittent Catheter with/without Hydrophilic CoatingThinkmed Medical Technology Co., Ltd.·2015-02-03
• K143182 — Speedicath Compact MaleColoplast A/S·2015-01-20
• K143594 — VaPro PocketHollister Incorporated·2015-01-09
• K141642 — VAPRO INTERMITTENT CATHETERHollister 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 CATHETERHollister Incorporated·2011-04-26
• K101900 — HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCHHakki 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 COMPACTColoplast Corp.·2007-11-09
• K063795 — GUARDIANCATHETER-URINARY DRAINAGE CATHETERMarian Medical, Inc.·2007-03-05
• K060268 — PEDIATRIC URINARY CATHETERClay Kennard·2006-02-24
• K050874 — ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETERAstra Tech, Inc.·2005-05-05
• K043241 — LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETERAstra Tech, Inc.·2004-12-23
• K031409 — URINARY CATHETERSPromedic, Inc.·2003-06-17
• K021938 — VITALCARE URETHRAL CATHETERVitalcare, Inc.·2003-04-22
• K023254 — SPEEDICATHColoplast Corp.·2003-01-27
• K020714 — RUSCH FLONEIL; FLOCATH INTROGELRusch Intl.·2002-07-01
• K012374 — MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETERAstra Tech, Inc.·2001-08-23
• K011552 — UROLOGICAL CATHETERApogee Medical, Inc.·2001-07-18
• K993651 — O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETERSc Hennig Enterprises Europe Srl·1999-12-23
• K992137 — UROLOGICAL CATHETERApogee, Inc.·1999-09-03
• K973120 — READYCATH CATHETERMedical Technologies of Georgia·1998-02-25
• K970704 — PERSONAL CATHETERRochester Medical Corp.·1997-03-13
• K965067 — DILATION CATHETER, BALLOONBoston Scientific Corp·1997-01-28
• K961361 — ASTA-CATHA+ Products·1996-10-31
• K952924 — ADI CATHETER WITH VALVEAsia Dynamics, Inc.·1995-08-18
• K943851 — ALL SILICONE INTERMITTENT CATHETERRochester Medical Corp.·1995-01-31
• K941672 — URI-CATH CATHETERGesco Intl., Inc.·1994-05-16
• K926369 — WALTHER CATHETERS, MALE, FEMALEThomasville Medical Assoc.·1993-05-21
• K914905 — ENTRAC(TM) URETHRAL MEASURING CATHETERAmerican Medical Systems, Inc.·1992-03-20
• K910876 — AUTOCATH(TM) SETCook Urological, Inc.·1991-05-28
• K901441 — ALBERT MORTON UROLOGICAL CATHETERTransinternational Marketing Group·1990-06-22
• K901336 — ASI HEMOSTASIS CATHETERAdvanced Surgical Intervention, Inc.·1990-06-20
• K892442 — KENDALL CURITY URETHRAL CATHETERSThe Kendal Co.·1989-06-23
• K881667 — KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATHThe Kendal Co.·1988-08-12
• K871999 — MMG URO-SELF CATHETERMedical Marketing Group·1987-08-25
• K830840 — OPEN ENDED URETERAL CATHETERVan-Tec, Inc.·1983-04-06
• K760093 — CATHETER, SILICONE FOLEY (BARDEX)C.R. Bard, Inc.·1976-08-23
• K760253 — TRAY, UNIVERSAL FOLY WO/DRAINAGE BAGC.R. Bard, Inc.·1976-08-23
• K760254 — TRAY, FOLEY CATHETERC.R. Bard, Inc.·1976-08-23