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Data / Medical devices / Device, Intravascular Catheter Securement

Device, Intravascular Catheter Securement (KMK): 130 FDA-registered makers in 21 countries

130 establishments in 21 countries are registered with the FDA to make Device, Intravascular Catheter Securement (product code KMK, Class 1, 21 CFR 880.5210). 4 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 64 510(k) clearances under this code, the latest on July 9, 2019, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KMK
Device class
1
Regulation
880.5210
Medical specialty
General Hospital

Makers by country

CountryMakers
United States57
China30
Mexico12
United Kingdom5
Taiwan3
India2
Dominican Republic2
Germany2
South Korea2
Guatemala2
Egypt2
Israel2
Switzerland1
Spain1
Belgium1
Canada1
Austria1
Sweden1
Indonesia1
Turkey1
France1

Makers of Device, Intravascular Catheter Securement

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
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1March 7, 1994000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1March 7, 1994000api.fda.gov
Interrad Medical IncMinneapolis, MN, United StatesManufacturer1July 9, 2019000api.fda.gov
TNT Moborg Intl. Ltd.Williamsville, NY, United StatesSpecification developer1July 14, 1994000api.fda.gov
Abiomed, Inc.Danvers, MA, United StatesManufacturer0000api.fda.gov
Alera Medtech LLCBuckley, WA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Alger Technology Co., Ltd.Taichung City, TaiwanManufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Applied Technology International, Ltd Dba:fabrifoam ProductsExton, PA, United StatesContract manufacturer0000api.fda.gov
ARGENTUM MEDICAL, LLC dba Bravida MedicalGeneva, IL, United StatesManufacturer0000api.fda.gov
Avacen, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Affix Medical - mHUB FacilityChicago, IL, United StatesSpecification developer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoContract manufacturer, Exporter to the US, Repackager or relabeler0000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer0000api.fda.gov
B. Braun Dominican Republic Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer0000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer0000api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanyExporter to the US, Specification developer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
BD Switzerland SarlEysins Vaud, SwitzerlandManufacturer0000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer0000api.fda.gov
Becton Dickinson, S.A.SAN AGUSTIN DE GUADALIX Madrid(Province), SpainContract manufacturer0000api.fda.gov
BEDAL International NVDiepenbeek Limburg, BelgiumManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Boyd CorporationJuarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer0030api.fda.gov
Bioteque Corporation I-Lan Factory IISu-Ao Cheng Yilan, TaiwanManufacturer0000api.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
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
Cath Dry Global, IncLos Angeles, CA, United StatesSpecification developer0000api.fda.gov
Cathaid IncorporatedMartinez, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Clinical Innovations, LLCMurray, UT, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Convatec LimitedDeeside Flintshire, United KingdomManufacturer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Covalon Technologies Inc.MISSISSAUGA Ontario, CanadaComplaint file establishment, Foreign private label distributor, Specification developer0000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Datt Mediproducts Private LimitedSOHNA Haryana, IndiaManufacturer0000api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Derma Sciences Nantong IncorporationDEVELOPMENT Jiangsu, ChinaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DfixGIMPO Gyeonggi, South KoreaManufacturer0000api.fda.gov
Datascope Corp.Fairfield, NJ, United StatesSpecification developer0000api.fda.gov
FabriteqKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Greystone Medical, LLCWaterford, MI, United StatesSpecification developer0000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
Guangdong Tidakang Medical Technology Co., LtdZhongShan City Guangdong, ChinaManufacturer0000api.fda.gov
Guangxi Dezhiran Biotechnology Co., Ltd.nanning Guangxi, ChinaManufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hangzhou Jimushi Meditech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Henan Maidingkang Medical Technology Co., Ltd.Changyuan Henan, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Henso Medical (hangzhou) Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Hubei Junyan Medical Science & Technology Co., Ltd.Huanggang Hubei, ChinaContract manufacturer0000api.fda.gov
Hubei V-Medical Products Co., Ltd.Xiantao Hubei, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Huizhou RSP Technology Co.,ltdHuizhou Guangdong, ChinaManufacturer0000api.fda.gov
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
I.V. HouseSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Independence Products LtdSwindon Wiltshire, United KingdomManufacturer0000api.fda.gov
Innovative Medical Manufacturing Co.Zhunan Township, Miaoli County, TaiwanContract manufacturer, Contract sterilizer0000api.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
Jcmed Tianjin Import And Export Co., LtdTianjin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Javelo Health LimitedEdinburgh East Lothian, United KingdomComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Jiangsu Newvalue Medical Products Co., Ltd.Taizhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kimsbio Co., Ltd.Gwangju, South KoreaManufacturer0000api.fda.gov
KusmoChico, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Leonhard Lang GMBHINNSBRUCK Tirol, AustriaContract manufacturer0000api.fda.gov
Lockwood Industries, LLCValencia, CA, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Med Way Inc.Buford, GA, United StatesManufacturer0000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer0010api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptManufacturer0000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Neotech Products, LLCValencia, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Ningbo Kehu Medical Technology Co.,ltd.Ningbo Zhejiang, ChinaForeign private label distributor, Specification developer0000api.fda.gov
Nolato Meditor ABTOREKOV Skane, SwedenContract manufacturer0000api.fda.gov
North American Rescue, LLC.Greer, SC, United StatesSpecification developer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
P.T. Sankei Medical IndustriesCIKANDE SERANG Banten, IndonesiaManufacturer0000api.fda.gov
Pharmaplast S.A.E.ALEXANDRIA Al Iskandariyah, EgyptContract manufacturer, Manufacturer0000api.fda.gov
Polarseal Tapes And ConversionsSaxmundham Suffolk, United KingdomManufacturer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
Posey, S. de R.L. de C.V.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
QTREX Quantum LtdRa'anana Central, IsraelManufacturer0000api.fda.gov
Quest Medical, Inc.Allen, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Roosin Medical Co., Ltd.Taizhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer0000api.fda.gov
Sam Medical ProductsTualatin, OR, United StatesSpecification developer0000api.fda.gov
Shandong Fengao Medical Technology Co., Ltd.Zibo Shandong, ChinaManufacturer0000api.fda.gov
Shandong Shinemed Technology Co., Ltd.ZIBO Shandong, ChinaContract manufacturer0000api.fda.gov
Shandong Shinrise Medical Supplies Co., LtdZibo Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shandong Succare Medical Co., Ltd.Zibo City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Iso Medical Products Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
SMD Manufacturing LLCSalt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sna Safehealth Solutions Inc.Monrovia, CA, United StatesSpecification developer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer0000api.fda.gov
Strukmyer MedicalMesquite, TX, United StatesContract manufacturer0000api.fda.gov
Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.Tekirdag, TurkeyContract manufacturer, Manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Terumo Medical Products (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
The Electrode StoreBuckley, WA, United StatesManufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer0000api.fda.gov
Trummed Medical (hangzhou) Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer0000api.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
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer0000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
WeslacovaNorth Wilkesboro, NC, United StatesContract manufacturer0000api.fda.gov
Waismed Ltd.Rosh Haayin Central, IsraelManufacturer0000api.fda.gov
Yafho Bio-Technology Co., Ltd.GUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTDWenzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Longterm Medical Technology Co., LTDHuzhou City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Wellong Medical Technology Co., LtdHuzhou City Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated July 9, 2019. 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.