Data / Medical devices / Catheter, Straight
Catheter, Straight (EZD): 49 FDA-registered makers in 17 countries
49 establishments in 17 countries are registered with the FDA to make Catheter, Straight (product code EZD, Class 2, 21 CFR 876.5130). 32 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 87 510(k) clearances under this code, the latest on September 23, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EZD
- Device class
- 2
- Regulation
- 876.5130
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 15 |
| United States | 11 |
| Mexico | 5 |
| Hungary | 2 |
| United Kingdom | 2 |
| Ireland | 2 |
| Malaysia | 2 |
| Denmark | 1 |
| Sweden | 1 |
| Netherlands | 1 |
| Costa Rica | 1 |
| Lithuania | 1 |
| Slovakia | 1 |
| Dominican Republic | 1 |
| Taiwan | 1 |
| Vietnam | 1 |
| Turkey | 1 |
Makers of Catheter, Straight
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 9 | July 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Hungary KFT | NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary | Manufacturer | 8 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Wellspect Healthcare | Molndal Vastra Gotaland, Sweden | Manufacturer, Specification developer | 8 | July 17, 2026 | 0 | 1 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 7 | August 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| HR PHARMACEUTICALS, INC d/b/a HR HealthCare | York, PA, United States | Complaint file establishment, Specification developer | 4 | June 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 3 | May 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hollister ULC | REHINS BALLINA Mayo, Ireland | Manufacturer | 3 | May 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hollister Services BV | Roosendaal Noord-Brabant, Netherlands | Manufacturer | 3 | May 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Specification developer | 2 | September 20, 2017 | 0 | 2 | 0 | api.fda.gov |
| Compactcath, Inc | Palo Alto, CA, United States | Specification developer | 2 | June 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Convatec Limited | Deeside Flintshire, United Kingdom | Specification developer | 2 | November 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Chengdu Daxan Innovative Medical Tech. Co., Ltd. | chengdu Sichuan, China | Manufacturer | 2 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Costa Rica SA | La Lima, Guadalupe Cartago, Costa Rica | Manufacturer | 2 | July 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Greystone Medical, LLC | Waterford, MI, United States | Specification developer | 2 | October 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 2 | June 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hollister Lietuva UAB | Kaunas district, Lithuania | Manufacturer | 2 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 2 | February 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 2 | May 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Adapta Medical, Inc. | Colorado Springs, CO, United States | Complaint file establishment, Manufacturer | 1 | August 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 1 | August 21, 2009 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 1 | October 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 1 | December 19, 2007 | 0 | 0 | 0 | api.fda.gov |
| Coloplast (china) Ltd. | ZHUHAI Guangdong, China | Manufacturer | 1 | December 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | November 7, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 1 | November 7, 1997 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Hungary, KFT | Tatabanya, Hungary | Manufacturer | 1 | April 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Footprint Medical Inc. | San Antonio, TX, United States | Manufacturer | 1 | August 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | May 13, 2008 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Specification developer | 1 | May 13, 2008 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical | ATHLONE Westmeath, Ireland | Specification developer | 1 | September 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 1 | September 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Unomedical S.R.O. | MICHALOVCE Kosicky, Slovakia | Manufacturer | 1 | January 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| CEA Global Dominicana d.b.a. Nissha Medical Technologies | San Pedro de Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Shuyang Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davol Surgical Innovations | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haiyan Kangyuan Medical Instrument Co.,ltd. | JiaXing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Bever Medical Devices Co., Ltd. | Hangzhou Zhejiang, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Medical Manufacturing Co. | Zhunan Township, Miaoli County, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integral Medical Products Co., Ltd. | SHAOXING Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Madewell Medical Technology (malaysia) Sdn., Bhd. | Kuala Ketil Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditec Technology Company Limited | Bac Ninh, Vietnam | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellspect Medikal A.S. | Kahramankazan Ankara, Turkey | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.