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Data / Medical devices / Tubes, Vials, Systems, Serum Separators, Blood Collection / United States

FDA-registered makers of Tubes, Vials, Systems, Serum Separators, Blood Collection in the United States: 44 establishments

44 establishments in the United States are registered with the FDA to make Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA). 30 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 3, 2026.

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Device
Tubes, Vials, Systems, Serum Separators, Blood Collection
Product code
JKA
Country
United States

Makers of Tubes, Vials, Systems, Serum Separators, Blood Collection in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer31April 15, 20260321api.fda.gov
Becton, Dickinson & Co.Broken Bow, NE, United StatesManufacturer13March 13, 2026000api.fda.gov
Greiner Bio-One North America, Inc.Monroe, NC, United StatesManufacturer8January 27, 20030160api.fda.gov
BD Puerto Rico LLCJuncos, PR, United StatesManufacturer7April 10, 2026000api.fda.gov
Becton, Dickinson & Co., (BD)Sumter, SC, United StatesManufacturer7April 10, 2026000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer5April 10, 2026000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer5July 21, 2008000api.fda.gov
Kurin, Inc.San Diego, CA, United StatesManufacturer4April 28, 2023000api.fda.gov
Sol-Millennium Medical, Inc.Chicago, IL, United StatesComplaint file establishment, Specification developer4April 30, 2025000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesManufacturer, Specification developer3February 27, 2025010api.fda.gov
Innovative Medical Technologies, IncOverland Park, KS, United StatesComplaint file establishment, Specification developer3September 29, 2023000api.fda.gov
Magnolia Medical Technologies, Inc.Seattle, WA, United StatesManufacturer3September 25, 2025020api.fda.gov
Tri-Tech Forensics, Inc.Leland, NC, United StatesManufacturer, Specification developer3June 16, 1997000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Specification developer2November 12, 1998020api.fda.gov
ICU Medical, Inc.Southington, CT, United StatesManufacturer2July 14, 1995000api.fda.gov
Retractable Technologies, Inc.Little Elm, TX, United StatesComplaint file establishment, Manufacturer2April 9, 2021000api.fda.gov
Avia VascularSalt Lake City, UT, United StatesComplaint file establishment, Specification developer1July 14, 2022000api.fda.gov
Bio-Analysis, Inc.Santa Monica, CA, United StatesManufacturer1November 19, 2014000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesManufacturer, Specification developer1June 3, 2009000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1September 27, 1988000api.fda.gov
Cardinal HealthNorfolk, NE, United StatesContract manufacturer, Manufacturer1September 27, 1988000api.fda.gov
Ecomed Solutions, LLCLindenhurst, IL, United StatesComplaint file establishment, Specification developer1December 22, 2023000api.fda.gov
Home Access Health Corp.Hoffman Est, IL, United StatesManufacturer1November 9, 2007000api.fda.gov
Labcorp GeneticsSan Francisco, CA, United StatesSpecification developer1May 12, 1997000api.fda.gov
Menarini Silicon Biosystems Inc.Huntingdon Valley, PA, United StatesSpecification developer1August 8, 2003000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer1July 14, 1995010api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1June 15, 2006000api.fda.gov
The Monarch Company, LLCBirmingham, AL, United StatesComplaint file establishment, Specification developer1December 4, 2023000api.fda.gov
Venocare, Inc.Doral, FL, United StatesComplaint file establishment, Specification developer1May 23, 2025000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer1August 3, 1993000api.fda.gov
Aivita Biomedical, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Alom Technologies CorporationFremont, CA, United StatesContract manufacturer0000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Cathtek LLCWalkertown, NC, United StatesContract manufacturer0000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer0000api.fda.gov
Carclo Technical Plastics - LatrobeLatrobe, PA, United StatesContract manufacturer0000api.fda.gov
Eastern Business Forms, LLCGreenville, SC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Peak 5 Packaging LLCOmaha, NE, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Amery, WI, United StatesContract manufacturer0000api.fda.gov
Sterigenics U.S., LLCHaw River, NC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov

Updated November 3, 2026. 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.