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Data / Medical devices / Infusor, Pressure, For I.V. Bags

Infusor, Pressure, For I.V. Bags (KZD): 56 FDA-registered makers in 9 countries

56 establishments in 9 countries are registered with the FDA to make Infusor, Pressure, For I.V. Bags (product code KZD, Class 1, 21 CFR 880.5420). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on February 17, 1998, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KZD
Device class
1
Regulation
880.5420
Medical specialty
General Hospital

Makers by country

CountryMakers
China19
United States18
Mexico6
Taiwan4
Germany3
Indonesia2
United Kingdom2
Austria1
South Korea1

Makers of Infusor, Pressure, For I.V. Bags

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
Medical Solutions, Inc.Chantilly, VA, United StatesSpecification developer1October 29, 1997000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Amis (xiamen) Cultural Creativity Co., LtdXiamen Fujian, ChinaManufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
Biegler GMBHMAUERBACH Niederosterreich, AustriaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
CovidienCiudad Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer0000api.fda.gov
Foremount Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaManufacturer0000api.fda.gov
Guangzhou Amk Medical Equipment Co.,ltd.Guang zhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer, Specification developer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanManufacturer0000api.fda.gov
Mason Tayler Medical Products Corp.Buffalo, NY, United StatesSpecification developer0000api.fda.gov
Mcreat ( Guangzhou ) Bio-Tech Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer0000api.fda.gov
MEDIKAN CO., Ltd.Gangseo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer0010api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Ningbo Albert Novosino Co., Ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Kk-Bioscience Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoManufacturer, Specification developer0000api.fda.gov
PT Newlife Healthcare InternationalKota Administrasi Jakarta Utara, IndonesiaManufacturer0000api.fda.gov
Purple Surgical International LimitedHerts England, United KingdomSpecification developer0000api.fda.gov
Purple Surgical Manufacturing LimitedTaunton Somerset, United KingdomContract manufacturer0000api.fda.gov
Renu Medical, Inc.Everett, WA, United StatesComplaint file establishment, Repackager or relabeler, Reprocessor0000api.fda.gov
Rudolf Riester GMBHJUNGINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Shanghai Gaohui Rubber And Plastic Products Co., LtdShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Med-Link Electronics Tech Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Sugih Instrumendo Abadi, PTBandung Barat Jawa Barat, IndonesiaManufacturer0000api.fda.gov
Sunmed Ap, Ltd.ZHUHAI Guangdong, ChinaContract manufacturer0000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer0000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoManufacturer0000api.fda.gov
Shanghai Caremate Medical Device Co. LtdShanghai, ChinaManufacturer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCEden Prairie, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Suzhou Minhua Medical Equipment Co.,Ltd.SuZhou Jiangsu, ChinaManufacturer0000api.fda.gov
The Metrix CompanyDubuque, IA, United StatesContract manufacturer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
TapmedicJacksonville, FL, United StatesSpecification developer0000api.fda.gov
Tiantai Shengtengyun Medical Supplies Co., Ltd.TIANTAI COUNTY Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Unimax Medical Systems Inc.New Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Unimax Medical Systems Inc.Yilan County, TaiwanManufacturer0000api.fda.gov
Unimed Medical Supplies IncShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
VBM Medizintechnik GMBHSULZ AM NECKAR Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Vistar Medical Supplies Co., Ltd.SHENZHEN Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Wenzhou Longwan Medical Device FactoryWenzhou Zhejiang, ChinaManufacturer0000api.fda.gov

Updated February 17, 1998. 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.