Panels › Gastroenterology, Urology › Product code EZD · Class 2
Catheter, Straight
Regulation 876.5130
11510(k)s in 12 months (87 all time)
0recalls in 12 months (13 all time)
12recalls that name a 510(k)
Top companies in EZD
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 5 | 7 |
| Coloplast | 12 | 0 |
| Convatec | 6 | 0 |
| Cure Medical, LLC | 3 | 2 |
| Hollister Incorporated | 5 | 0 |
| Compactcath, Inc. | 3 | 0 |
| Well Lead Medical Co., Ltd. | 3 | 0 |
| Wellspect AB | 3 | 0 |
| Wellspect HealthCare (Division of DENTSPLY IH AB) | 0 | 3 |
| Adapta Medical, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K261418 | Liquick X-treme, Liquick X-treme Plus Teleflex Medical, IE | EZD |
| Aug 5, 2026 | K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Inte Convatec, GB | EZD |
| Jul 17, 2026 | K261658 | LoFric Origo Pro Coudé Wellspect AB, SE | EZD |
| Jul 7, 2026 | K262045 | Luja Soft Coloplast A.S. | EZD |
| Jun 24, 2026 | K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) Hangzhou Jimushi Meditech Co., Ltd., CN | EZD |
| May 18, 2026 | K253295 | Coude Sleeved IC; Coude Plus Sleeved IC Hollister Incorporated | EZD |
| Apr 24, 2026 | K260999 | LoFric Elle Pro Wellspect AB, SE | EZD |
| Apr 1, 2026 | K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women Convatec Limited, GB | EZD |
| Mar 12, 2026 | K260502 | Liv Pre-lubricated Intermittent Catheter HR Healthcare | EZD |
| Jan 29, 2026 | K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter K HR Healthcare | EZD |
| Jan 2, 2026 | K251178 | Ready to use Nelaton Catheter Jamjoom Fullcare Corporation, CN | EZD |
| Oct 3, 2025 | K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (na Hollister Incorporated | EZD |
| Sep 26, 2025 | K250659 | LoFric Origo Wellspect AB, SE | EZD |
| Jul 1, 2025 | K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Convatec, GB | EZD |
| Jun 27, 2025 | K251116 | Luja Coudé Coloplast Corp. | EZD |
| Jun 26, 2025 | K243175 | Disposable Intermittent Catheter (TPU Catheter) Chengdu Daxan Innovative Medical Tech. Co., Ltd., CN | EZD |
| Apr 17, 2025 | K250270 | Luja Set Coloplast Corp. | EZD |
| Nov 26, 2024 | K242049 | SureCath Set Coloplast Corp. | EZD |
| Nov 21, 2024 | K241210 | Luja Coude Coloplast Corp. | EZD |
| Jul 26, 2024 | K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) Coloplast | EZD |
| May 3, 2024 | K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket Hollister Incorporated | EZD |
| Jan 25, 2024 | K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) Convatec, GB | EZD |
| Nov 8, 2023 | K230400 | Cure Catheter Closed System; Cure Dextra Closed System Convatec, Inc. | EZD |
| Oct 26, 2023 | K233101 | Luja Coude (20108 Male CH18 - large packaging) Coloplast Corp. | EZD |
| Aug 25, 2023 | K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size) Coloplast | EZD |
| May 22, 2023 | K220722 | PVC Hydrophilic Urethral Catheter Well Lead Medical Co., Ltd., CN | EZD |
| May 4, 2023 | K223756 | SimPro Now, GentleCath Hydrophilic Dentsply Sirona | EZD |
| Apr 5, 2023 | K222677 | Intermittent nelaton catheter for single use Hangzhou Jimushi Meditech Co., Ltd., CN | EZD |
| Dec 8, 2022 | K220667 | Sleeved IC Hollister Incorporated | EZD |
| Dec 7, 2022 | K212567 | PVC Hydrophilic Urethral Catheter Chengdu Daxan Innovative Medical Tech. Co., Ltd., CN | EZD |
| Dec 2, 2022 | K221401 | Self-Cath and Self-Cath Plus Coloplast | EZD |
| Nov 17, 2022 | K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus Convatec, Inc. | EZD |
| Sep 21, 2022 | K222059 | SpeediCath Flex Set Coloplast | EZD |
| Sep 13, 2022 | K213575 | Female IC (Not Finalized) Hollister Incorporated | EZD |
| Apr 29, 2022 | K212430 | BONREE Nelaton Catheter Bonree Medical Co., Ltd., CN | EZD |
| Apr 26, 2022 | K210250 | SpeedCath Compact Male Coloplast | EZD |
| Mar 8, 2022 | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) Coloplast | EZD |
| Feb 17, 2022 | K211212 | LoFric Elle Dentsply Sirona | EZD |
| Sep 30, 2020 | K202566 | Wiygul Catheter Big Blue Biotech, Inc. | EZD |
| Oct 1, 2018 | K181445 | AMSure Hydrophilic Intermittent Catheter Amsino International, Inc. | EZD |
| Jun 14, 2018 | K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter Compactcath, Inc. | EZD |
| Feb 22, 2018 | K172541 | Medline Catheter Specimen Collector Medline Industries, Inc. | EZD |
| Oct 13, 2017 | K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) Zhanjiang Star Enterprise Co., Ltd., CN | EZD |
| Sep 20, 2017 | K172247 | Magic3 Go Intermittent Urinary Catheter C.R. Bard, Inc. | EZD |
| Aug 16, 2016 | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C Adapta Medical, Inc. | EZD |
| Apr 26, 2016 | K160858 | CompactCath Intermittent Urinary Catheter Compactcath, Inc. | EZD |
| Mar 3, 2016 | K151745 | FULL CARE Disposable PVC Nelaton Catheter Shaoxing Fuqing Health Products Co., Ltd., CN | EZD |
| May 11, 2015 | K150345 | Magic3 Go Intermittent Urinary Catheter C.R. Bard, Inc. | EZD |
| Oct 31, 2014 | K142575 | Bard RiteCath Intermittent Urinary Catheter C.R. Bard, Inc. | EZD |
| Oct 28, 2014 | K142563 | Well Lead PVC Urethral Catheter Well Lead Medical Co., Ltd., CN | EZD |
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