Product Code: GBM


Products Classified as GBM

1927Catheter, UrethralUrological Catheter And Accessories.

Total Product Life Cycle (TPLC) Devices

1927Catheter, UrethralUrological Catheter And Accessories.

FDA Consensus Standards

Catheter, Urethral [32384]21 CFR §876.5130 🔎

Pre-market Notifications for GBM

K213283GentleCath Air For Men Hydrophilic Intermittent Urinary CatheterConvaTec Limited
K211436Intermittent Catheter (Not Finalized)Hollister Incorporated
K200142SpeediCath SoftColoplast
K200134Jimushi Sterile Urethral Catheter For Single UseHangzhou Jimushi Meditech Co., Ltd.
K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated
K192577Actreen Hi-Lite Intermittent Urinary CathetersB. Braun Medical Inc.
K192468Male, 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; MaHangzhou Bever Medical Devices Co., Ltd.
K191633Infyna ChicHollister Incorporated
K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc.
K190620SpeediCath Flex Coude ProColoplast
K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent CatheterTeleflex Medical, Inc
K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated
K182511SimplCathF&S Medical Solutions, LLC
K181206GentleCath Glide Intermittent Urinary CatheterConvaTec Limited
K180824VaPro 2 Intermittent CatheterHollister Incorporated

Global Unique Device Identification Database

20610075205305CATHETER, URETHRAL
20610075205299CATHETER, URETHRAL
20610075205282CATHETER, URETHRAL
20610075205275CATHETER, URETHRAL
20610075205268CATHETER, URETHRAL
20610075205251CATHETER, URETHRAL
20610075205244CATHETER, URETHRAL
20610075205237CATHETER, URETHRAL
20610075205220CATHETER, URETHRAL
20610075205213CATHETER, URETHRAL
20610075205206CATHETER, URETHRAL
20610075205190CATHETER, URETHRAL
20610075205183CATHETER, URETHRAL
20610075205176CATHETER, URETHRAL
20610075205169CATHETER, URETHRAL

Maude Adverse Events

FLOCATH QUICK KIT - 16 FTELEFLEX MEDICAL SDN. BHD.2020-03-27
MMG H2O 8FR 100/BXTELEFLEX MEDICAL SDN. BHD.2020-03-27
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-03-24
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-03-24
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-03-24
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-03-24
SPEEDICATH FLEX COUDE PRO CATHETERCOLOPLAST HUNGARY KFT2020-03-16
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-03-12
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-02-27
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-02-24
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-02-18
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-02-07
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-02-05
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-02-05
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-01-27
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-01-23
VAPRO HYDROPHILIC IC CH14 16 IN COUDEHOLLISTER INCORPORATED2020-01-22
VAPRO STANDARD CH 14 40 CM INTERMITTENT CATHETERHOLLISTER INCORPORATED2020-01-21
BARDEX? ALL-SILICONE FOLEY CATHETERC.R. BARD, INC. (COVINGTON) -10182332020-01-06
GENTLECATH GLIDEUNOMEDICAL S.R.O.2020-01-02
GENTLECATH GLIDEUNOMEDICAL S.R.O.2020-01-02
GENTLECATH GLIDEUNOMEDICAL S.R.O.2020-01-02
GENTLECATH GLIDEUNOMEDICAL S.R.O.2020-01-02
GENTLECATH GLIDEUNOMEDICAL S.R.O.2020-01-02
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31
GENTLE CATHUNOMEDICAL S.R.O.2019-12-31

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