Skip to the page

Data / Medical devices / Accessories, Pump, Infusion

Accessories, Pump, Infusion (MRZ): 24 FDA-registered makers in 9 countries

24 establishments in 9 countries are registered with the FDA to make Accessories, Pump, Infusion (product code MRZ, Class 2, 21 CFR 880.5725). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on June 15, 2023, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
MRZ
Device class
2
Regulation
880.5725
Medical specialty
General Hospital

Makers by country

CountryMakers
United States13
Germany4
Costa Rica1
Mexico1
South Korea1
Italy1
Israel1
France1
Turkey1

Makers of Accessories, Pump, Infusion

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
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer4August 25, 2017020api.fda.gov
American I.V. Products, Inc.Harmans, MD, United StatesManufacturer2December 18, 2014000api.fda.gov
ICU Medical Costa Rica Ltd.La Aurora de Heredia, Costa RicaManufacturer2August 25, 2017000api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer2October 17, 2007000api.fda.gov
WelldocColumbia, MD, United StatesManufacturer2April 7, 2020000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1August 2, 2018000api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanyExporter to the US, Specification developer1March 12, 2020000api.fda.gov
Border Assembly S de RL de CVTIJUANA Baja California, MexicoComplaint file establishment, Manufacturer1June 15, 2023000api.fda.gov
Carelife (usa) Inc.Alpharetta, GA, United StatesSpecification developer1March 26, 2021000api.fda.gov
Elite Biomedical Solutions LLCCincinnati, OH, United StatesManufacturer1April 29, 2022000api.fda.gov
Ivwatch, LLCNewport News, VA, United StatesManufacturer1February 13, 2015000api.fda.gov
Roche Diabetes Care GmbHMannheim Baden-Wurttemberg, GermanyManufacturer1May 15, 2008000api.fda.gov
Sooil Development Co., Ltd.Yongin-si Gyeonggi, South KoreaExporter to the US, Manufacturer1September 4, 2007000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
CANE' S.p.A.RIVOLI-CASCINE VICA Torino, ItalyManufacturer0000api.fda.gov
Eitan Medical LTDNetanya Central, IsraelComplaint file establishment, Manufacturer0000api.fda.gov
Fresenius Vial S.A.S.Brezins Isere, FranceManufacturer0000api.fda.gov
MIPM Mammendorfer Institut fur Physik und Medizin GmbHMAMMENDORF/MUNICH Bavaria, GermanyContract manufacturer0000api.fda.gov
MOMENI ENGINEERING dba Essex IndustriesHuntington Beach, CA, United StatesContract manufacturer0000api.fda.gov
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.Tire Izmir, TurkeyContract manufacturer, Contract sterilizer0000api.fda.gov
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Plexus Corp.Neenah, WI, United StatesContract manufacturer0000api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tandem Diabetes Care, INC.San Diego, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov

Updated June 15, 2023. 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.