Skip to the page

Data / Medical devices / Catheter, Cholangiography

Catheter, Cholangiography (GBZ): 34 FDA-registered makers in 8 countries

34 establishments in 8 countries are registered with the FDA to make Catheter, Cholangiography (product code GBZ, Class 1, 21 CFR 878.4200). 2 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on December 17, 1997, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
GBZ
Device class
1
Regulation
878.4200
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States18
Germany6
Mexico5
China1
Costa Rica1
Ireland1
India1
Brazil1

Makers of Catheter, Cholangiography

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
Atrium Medical CorporationMerrimack, NH, United StatesSpecification developer1October 4, 1983080api.fda.gov
Nashville Surgical InstrumentsSpringfield, TN, United StatesSpecification developer1December 17, 1997000api.fda.gov
Alleva Medical DevicesPomona, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
American Catheter CorpJupiter, FL, United StatesManufacturer0010api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aptyx - JaffreyJaffrey, NH, United StatesContract manufacturer0000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoManufacturer0000api.fda.gov
BAK KOHLER Medical KGNEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Beilun Plastech IncNingbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.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
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Koscher & Wuertz GMBHSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer0000api.fda.gov
Tecnocirurgica Comercio De Materiais Medicos Cirurgicos E Hospitalares LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN 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 developer0010api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer0000api.fda.gov

Updated December 17, 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.