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Data / Medical devices / Accessories, Catheter

Accessories, Catheter (KGZ): 138 FDA-registered makers in 21 countries

138 establishments in 21 countries are registered with the FDA to make Accessories, Catheter (product code KGZ, Class 1, 21 CFR 878.4200). 15 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on October 10, 2002, and lists 17 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
United States63
China24
Mexico11
Germany7
Taiwan6
Costa Rica4
India4
United Kingdom3
Czechia2
Dominican Republic2
Switzerland2
Belarus1
Ireland1
Turkey1
Canada1
Brazil1
Pakistan1
Malaysia1
Australia1
Denmark1
Poland1

Makers of Accessories, Catheter

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
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler2October 23, 1980000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2October 23, 1980040api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer, Repackager or relabeler1December 12, 1978000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaManufacturer1October 23, 1980000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1November 2, 1976010api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanyManufacturer1November 2, 1976000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Contract sterilizer, Repackager or relabeler1November 2, 1976000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1March 24, 1981000api.fda.gov
Cardinal Health Costa Rica, S.A.-- Alajuela, Costa RicaContract manufacturer, Manufacturer1March 24, 1981000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer1October 23, 1980000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1November 2, 1976000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler1November 2, 1976000api.fda.gov
Implantech Associates, Inc.Ventura, CA, United StatesManufacturer1January 26, 1996000api.fda.gov
MentorIrving, TX, United StatesSpecification developer1February 10, 1998000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1October 23, 1980000api.fda.gov
2G MedicalBelleair, FL, United StatesSpecification developer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Advanced Lifesciences Pvt. Ltd.New Delhi, IndiaContract manufacturer0000api.fda.gov
Advanced Vascular DynamicsTigard, OR, United StatesManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Alleva Medical (D.G.) LtdDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler0000api.fda.gov
Asomedica Co. LtdSmolevichi District Minsk, BelarusManufacturer0000api.fda.gov
AUSA Medical Device Pvt LtdBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
Atrium Medical CorporationMerrimack, NH, United StatesSpecification developer0000api.fda.gov
B. Braun Dominican Republic Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer0000api.fda.gov
B. Braun Medical AGESCHOLZMATT Luzern, SwitzerlandContract manufacturer0000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Baxter Healthcare CorporationCleveland, MS, United StatesManufacturer0000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bema-Gmbh & Co. KGEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer0000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesSpecification developer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, 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
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.Gebze Kocaeli, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Changzhou DSB Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Changzhou Newmed Micro-Medtech Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Chongqing Jinshan Science & Technology (group) Co., LtdChongqing, ChinaManufacturer0000api.fda.gov
Cole InstrumentsAlpharetta, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Coloplast Manufacturing Us, LLCMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
Conod Medical Shuyang Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaSpecification developer0000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0030api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer, Repackager or relabeler0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Enter Medical CorporationChiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesManufacturer0000api.fda.gov
Faga Medical Industria De Equipamentos E Instrumentos Medico Hospitalares Ltda MeBauru Sao Paulo, BrazilManufacturer0000api.fda.gov
Fortune Medical Instrument Corp.Taoyuan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Galt Medical Corp.Garland, TX, United StatesComplaint file establishment, Manufacturer0030api.fda.gov
Gemmy Industrial Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesManufacturer, Specification developer0000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hemedex IncorporatedNorth Waltham, MA, United StatesManufacturer0000api.fda.gov
HK Surgical, Inc.San Clemente, CA, United StatesSpecification developer0000api.fda.gov
Hospitech Manufacturing Services Sdn BhdShah Alam Selangor, MalaysiaManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heraeus Medical Components, SRLGuadalupe Cartago, Costa RicaContract 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 DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Insightra Medical, Inc.Clarksville, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Grit Medical Technology Co., Ltd.changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Kangjin Medical Instrument Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.Shuyang Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yangtze River Medical Technology Corp.Taizhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jigsaw Medical, LLCSaint Charles, IL, United StatesSpecification developer0000api.fda.gov
Jiangsu Hongsheng Bioengineering Co., Ltd.Nantong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kahlo Sciences, LLCCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Kmi Imi Group / Dba: Innovative Med, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Kung Shin Plastics Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
LiNA Medical AGRoot D4 Luzern, SwitzerlandExporter to the US, Manufacturer0000api.fda.gov
LiNA Medical ApSNaerum Hovedstaden, DenmarkSpecification developer0000api.fda.gov
LiNA Medical Polska sp. z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Marina Medical Instruments, Inc.Davie, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Marpac, Inc.Albuquerque, NM, United StatesManufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Mediplus Ltd.HIGH WYCOMBE, BUCKS Buckinghamshire, United KingdomComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medline Industries, LP - SPTWaukegan, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer0000api.fda.gov
Meridian Medical LimitedLittlehampton West Sussex, United KingdomContract manufacturer, Repackager or relabeler0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer0010api.fda.gov
Micro-Energy Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Micromedics, Inc.Saint Paul, MN, United StatesManufacturer0010api.fda.gov
MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA CellmyxCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer0000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
NDH Medical, Inc.Saint Petersburg, FL, United StatesContract manufacturer0000api.fda.gov
Ningbo Huakun Medical Equipment Co.,ltdCixi Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Luke Medical Devices Co., Ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nolato GW BETHELBethel, VT, United StatesContract manufacturer0000api.fda.gov
Nordson MEDICAL MexicoGuaymas Sonora, MexicoContract manufacturer, Exporter to the US0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesManufacturer0000api.fda.gov
PFM Medical, IncCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
PMT Corp.Chanhassen, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Poly Medicure Ltd.Faridabad Haryana, IndiaManufacturer0000api.fda.gov
Pacific Hospital Supply Co., LtdTongluo Township Miaoli, TaiwanManufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.Pinghu City Zhejiang, ChinaContract manufacturer0000api.fda.gov
Somavac Medical Solutions, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Sprenger GMBHFRITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesSpecification developer0000api.fda.gov
Suzhou Sunmed Co., LtdSUZHOU CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Taicang Yigao Medical Technology Co.,ltdTaicang Jiangsu, ChinaManufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Trinity Sterile, Inc.Salisbury, MD, United StatesManufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Uresil, LLCSkokie, IL, United StatesManufacturer0000api.fda.gov
Viant Medical, Inc.Grand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Wilson Instruments (sha) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Zhejiang Yigao Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov

Updated October 10, 2002. 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.