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Data / Medical devices / Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature / United States

FDA-registered makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK). 12 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Product code
FMK
Country
United States

Makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Accriva Diagnostics, Inc.San Diego, CA, United StatesManufacturer2March 2, 2023010api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer1April 18, 2012000api.fda.gov
BD Puerto Rico LLCJuncos, PR, United StatesManufacturer1December 16, 2022000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer1December 16, 2022020api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesComplaint file establishment, Specification developer1September 19, 2022000api.fda.gov
Clinical Innovations, LLCMurray, UT, United StatesComplaint file establishment, Manufacturer, Specification developer1February 24, 2023000api.fda.gov
Color Diagnostics, LLCSouth San Francisco, CA, United StatesSpecification developer1August 12, 2022000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1December 16, 2022000api.fda.gov
Genteel, LLCWest Linn, OR, United StatesComplaint file establishment, Manufacturer, Specification developer1May 12, 2016000api.fda.gov
Reddrop DXFort Collins, CO, United StatesSpecification developer1March 21, 2024000api.fda.gov
Tasso IncSeattle, WA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export1August 12, 2022000api.fda.gov
Yourbio HealthMinnetonka, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1April 19, 2023000api.fda.gov
Ambi, Inc.Capitola, CA, United StatesManufacturer0000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer0000api.fda.gov
Facet Technologies, LLC.Atlanta, GA, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesManufacturer for export0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.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

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.