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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

CountryMakers
China15
United States11
Mexico5
Hungary2
United Kingdom2
Ireland2
Malaysia2
Denmark1
Sweden1
Netherlands1
Costa Rica1
Lithuania1
Slovakia1
Dominican Republic1
Taiwan1
Vietnam1
Turkey1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coloplast A/SHUMLEBAEK Hovedstaden, DenmarkSpecification developer9July 7, 2026000api.fda.gov
Coloplast Hungary KFTNYIRBATOR Szabolcs-Szatmar-Bereg, HungaryManufacturer8June 27, 2025000api.fda.gov
Wellspect HealthcareMolndal Vastra Gotaland, SwedenManufacturer, Specification developer8July 17, 2026010api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer7August 5, 2026000api.fda.gov
HR PHARMACEUTICALS, INC d/b/a HR HealthCareYork, PA, United StatesComplaint file establishment, Specification developer4June 24, 2026000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer3May 18, 2026000api.fda.gov
Hollister ULCREHINS BALLINA Mayo, IrelandManufacturer3May 18, 2026000api.fda.gov
Hollister Services BVRoosendaal Noord-Brabant, NetherlandsManufacturer3May 18, 2026000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesSpecification developer2September 20, 2017020api.fda.gov
Compactcath, IncPalo Alto, CA, United StatesSpecification developer2June 14, 2018000api.fda.gov
Convatec LimitedDeeside Flintshire, United KingdomSpecification developer2November 8, 2023000api.fda.gov
Chengdu Daxan Innovative Medical Tech. Co., Ltd.chengdu Sichuan, ChinaManufacturer2June 26, 2025000api.fda.gov
Coloplast Costa Rica SALa Lima, Guadalupe Cartago, Costa RicaManufacturer2July 7, 2026000api.fda.gov
Greystone Medical, LLCWaterford, MI, United StatesSpecification developer2October 28, 2014000api.fda.gov
Hangzhou Jimushi Meditech Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer2June 24, 2026000api.fda.gov
Hollister Lietuva UABKaunas district, LithuaniaManufacturer2May 3, 2024000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer2February 22, 2018000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer, Manufacturer2May 22, 2023000api.fda.gov
Adapta Medical, Inc.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer1August 16, 2016000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer, Manufacturer1August 21, 2009000api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaManufacturer1October 1, 2018000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer1December 19, 2007000api.fda.gov
Coloplast (china) Ltd.ZHUHAI Guangdong, ChinaManufacturer1December 2, 2022000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1November 7, 1997000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer1November 7, 1997000api.fda.gov
Coloplast Hungary, KFTTatabanya, HungaryManufacturer1April 17, 2025000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer1August 12, 2009000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler1May 13, 2008000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesSpecification developer1May 13, 2008000api.fda.gov
Teleflex MedicalATHLONE Westmeath, IrelandSpecification developer1September 23, 2026000api.fda.gov
Teleflex Medical Sdn. Bhd.KAMUNTING Perak, MalaysiaManufacturer1September 23, 2026000api.fda.gov
Unomedical S.R.O.MICHALOVCE Kosicky, SlovakiaManufacturer1January 25, 2024000api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical TechnologiesSan Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Conod Medical Shuyang Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Haiyan Kangyuan Medical Instrument Co.,ltd.JiaXing Zhejiang, ChinaContract manufacturer0000api.fda.gov
Hangzhou Bever Medical Devices Co., Ltd.Hangzhou Zhejiang, ChinaSpecification developer0000api.fda.gov
Innovative Medical Manufacturing Co.Zhunan Township, Miaoli County, TaiwanContract manufacturer0000api.fda.gov
Integral Medical Products Co., Ltd.SHAOXING Zhejiang, ChinaContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Jiangsu Suyun Medical Materials Co., Ltd.Lianyungang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Madewell Medical Technology (malaysia) Sdn., Bhd.Kuala Ketil Kedah, MalaysiaContract manufacturer0000api.fda.gov
Meditec Technology Company LimitedBac Ninh, VietnamContract manufacturer, Contract sterilizer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Shaoxing Fuqing Health Products Co., Ltd.Shaoxing Zhejiang, ChinaContract manufacturer0000api.fda.gov
Wellspect Medikal A.S.Kahramankazan Ankara, TurkeyContract manufacturer, Contract sterilizer0000api.fda.gov
Xianju Bever Medical Devices Co., Ltd.Taizhou Zhejiang, ChinaContract manufacturer0000api.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.