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Data / Medical devices / Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (ONB): 22 FDA-registered makers in 8 countries

22 establishments in 8 countries are registered with the FDA to make Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB, Class 2, 21 CFR 880.5440). 14 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on December 5, 2025, and lists 14 recall events (1 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
ONB
Device class
2
Regulation
880.5440
Medical specialty
General Hospital

Makers by country

CountryMakers
United States10
Israel4
Mexico3
Thailand1
Switzerland1
China1
Spain1
Slovakia1

Makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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
Epic International (Thailand) Co., Ltd.Amphur Pluakdaeng Rayong, ThailandManufacturer10December 5, 2025000api.fda.gov
BD Switzerland SarlEysins Vaud, SwitzerlandManufacturer7September 12, 2025010api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer6September 12, 2025010api.fda.gov
Simplivia Healthcare Ltd.KIRYAT SHMONA Northern, IsraelManufacturer6August 5, 2025010api.fda.gov
Equashield LLCPort Washington, NY, United StatesManufacturer, Repackager or relabeler3February 17, 2023000api.fda.gov
Equashield Medical LtdTefen Northern, IsraelManufacturer3February 17, 2023000api.fda.gov
Equashield Medical LtdMigdal Tefen Northern, IsraelManufacturer3February 17, 2023000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler3August 31, 2018000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer, Specification developer2August 10, 2018000api.fda.gov
CarefusionSan Diego, CA, United StatesSpecification developer1March 24, 2023000api.fda.gov
CormedBar-Lev Northern, IsraelManufacturer1August 17, 2018000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesSpecification developer1August 31, 2018091api.fda.gov
Shandong Ande Healthcare Apparatus Co., Ltd.Zibo Shandong, ChinaManufacturer1November 23, 2022000api.fda.gov
Yukon Medical, LLCDurham, NC, United StatesComplaint file establishment, Manufacturer, Specification developer1March 2, 2021000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesContract manufacturer0000api.fda.gov
Becton Dickinson, S.A.SAN AGUSTIN DE GUADALIX Madrid(Province), SpainContract manufacturer0000api.fda.gov
Comar LLCWoodville, WI, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
SISTEMAS MEDICOS ALARIS, S.A De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
SKY Medical, a.s.Samorin Trnavsky, SlovakiaContract manufacturer0000api.fda.gov
Vault Paragon Group, Inc.Garden City, ID, United StatesContract manufacturer0000api.fda.gov

Updated December 5, 2025. 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.