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Data / Medical devices / Stylet For Catheter, Gastro-Urology

Stylet For Catheter, Gastro-Urology (EZB): 31 FDA-registered makers in 9 countries

31 establishments in 9 countries are registered with the FDA to make Stylet For Catheter, Gastro-Urology (product code EZB, Class 1, 21 CFR 876.5130). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on May 5, 1997, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EZB
Device class
1
Regulation
876.5130
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States17
Costa Rica3
Ireland2
Mexico2
Pakistan2
Germany2
Egypt1
India1
China1

Makers of Stylet For Catheter, Gastro-Urology

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
Ameco Medical Industries10TH OF RAMADAN CITY Ash Sharqiyah, EgyptContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0010api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Grace Manufacturing IncRussellville, AR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Heraeus Medical Components, LLCSaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Heraeus Medical Components, SRLGuadalupe Cartago, Costa RicaContract manufacturer0000api.fda.gov
Ilg Medizintechnik GMBHDURCHHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Resonetics, LLCBethel, CT, United StatesContract manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov

Updated May 5, 1997. 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.