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Data / Medical devices / Supplies, Blood-Bank

Supplies, Blood-Bank (KSS): 32 FDA-registered makers in 11 countries

32 establishments in 11 countries are registered with the FDA to make Supplies, Blood-Bank (product code KSS, Class 1, 21 CFR 864.9050). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on January 5, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KSS
Device class
1
Regulation
864.9050
Medical specialty
Hematology

Makers by country

CountryMakers
United States18
China3
United Kingdom2
Japan2
Poland1
Italy1
Dominican Republic1
Germany1
Malaysia1
Canada1
Israel1

Makers of Supplies, Blood-Bank

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
Advanced Engineering, Inc.Huntington, IN, United StatesContract manufacturer0000api.fda.gov
Alba Bioscience LimitedPENICUIK Midlothian, United KingdomManufacturer0000api.fda.gov
Alpha Scientific Corp.Exton, PA, United StatesManufacturer0000api.fda.gov
Ashland Specialty Ingredients, G.P.Bridgewater, NJ, United StatesManufacturer, Specification developer0000api.fda.gov
Baxter Healthcare CorporationCleveland, MS, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Clinico Medical Sp. z o.o.Blonie/Miekinia Dolnoslaskie, PolandManufacturer0000api.fda.gov
Delcon SRLGrassobbio Bergamo, ItalyManufacturer0000api.fda.gov
Fenwal International, Inc.HAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Fenwal, Inc.Lake Zurich, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Fresenius Hemocare GMBHFriedberg Hesse, GermanyManufacturer0000api.fda.gov
Fresenius Kabi WarrendaleWarrendale, PA, United StatesManufacturer0000api.fda.gov
GVS TM, Inc.Covina, CA, United StatesManufacturer0000api.fda.gov
Immucor, Inc.Norcross, GA, United StatesManufacturer, Specification developer0000api.fda.gov
Itl Asia Pacific Sdn BhdBatu Gajah Perak, MalaysiaManufacturer0000api.fda.gov
Jiangsu Goju Identification Technology Co., Ltd.YANCHENG CITY Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
LCR Hallcrest, LLC. (IL)Glenview, IL, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Micro Typing Systems, Inc.Pompano Beach, FL, United StatesSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Nichiryo Co., LtdSaitama-City, JapanManufacturer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Radtag Technologies, Inc.EDMONTON Alberta, CanadaManufacturer0000api.fda.gov
Shenzhen Lilian Precision Mould Manufacturing Co., Ltd.Shenzhen City Guangdong, ChinaContract manufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov
Timestrip Uk LimitedSUDBURY Suffolk, United KingdomSpecification developer0000api.fda.gov
Terumo BCT, Inc..Lakewood, CO, United StatesManufacturer0000api.fda.gov
Terumo Corporation Fujinomiya FactoryFUJINOMIYA-SHI Shizuoka, JapanManufacturer0000api.fda.gov
Timestrip Technical Services Ltd.Even Yehuda Central, IsraelManufacturer0000api.fda.gov
Typenex Medical, LLCChicago, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Web IndustriesDayville, CT, United StatesContract manufacturer0000api.fda.gov
Zebra Technologies CorporationMorris Plains, NJ, United StatesManufacturer0000api.fda.gov

Updated January 5, 1988. 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.