Data / Medical devices / United States / Millyard Advanced Medical Products LLC

Millyard Advanced Medical Products LLC: FDA-registered device maker in Manchester, NH, United States, 9 510(k) clearances

Name: Millyard Advanced Medical Products LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Millyard Advanced Medical Products LLC is registered with the FDA (registration 3016798778) in Manchester, NH, United States. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 1, 2025. Registered through 2027. FDA data exported November 3, 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.

Get makers like this one Watch Millyard Advanced Medical Products LLC

FDA registration number: 3016798778
Address: 540 Commercial Street Suite 306, Manchester, NH, United States, 03101
Owner or operator: Millyard Advanced Medical Products LLC (10072764)
Roles: Complaint file establishment, Manufacturer
First device listed: May 1, 2020
Registered through: 2027
Brand names listed: Remunity Pump for Remodulin (treprostinil) Injection, Remunity System, Remunity" Pump for Remodulin (treprostinil) Injection, Twiist Automated Insulin Delivery System, iiSure Infusion Set, twiist Automated Insulin Delivery System

Devices it lists

Device	Product code	Class	Role	Source
Alternate Controller Enabled Insulin Infusion Pump	QFG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Calculator, Drug Dose	NDC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Controller, Infusion, Intravascular, Electronic	LDR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Infusion Pump, Drug Specific, Pharmacy-Filled	QJY	2	Manufacturer	accessdata.fda.gov
Insulin Pump Secondary Display	PKU	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Interoperable Automated Glycemic Controller	QJI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 1, 2025	K243841	Sparta Infusion Set for Insulin	FPA	Substantially Equivalent	Deka Research and Development	accessdata.fda.gov
April 2, 2025	K250930	twiist system	QFG	Substantially Equivalent	Deka Research & Development Corp.	accessdata.fda.gov
March 11, 2025	K250357	RemunityPRO Pump for Remodulin® (treprostinil) Injection	FRN	Substantially Equivalent	Deka Research & Development Corp.	accessdata.fda.gov
January 16, 2025	K241736	Remunity 2.0 Pump for Remodulin (treprostinil) Injection	FRN	Substantially Equivalent	Deka Research and Development Corp.	accessdata.fda.gov
November 27, 2024	K243354	Remunity System	QJY	Substantially Equivalent	Deka Research & Development Corp.	accessdata.fda.gov
October 7, 2024	K242693	DEKA Infusion System, DEKA Administration Set	LDR	Substantially Equivalent	Deka Research and Development Corporation	accessdata.fda.gov
May 24, 2024	K241178	DEKA ACE Pump System	QFG	Substantially Equivalent	Deka Research and Development	accessdata.fda.gov
March 13, 2024	K234055	DEKA Loop	QJI	Substantially Equivalent	Deka Research and Development	accessdata.fda.gov
February 21, 2020	K191313	Unity Subcutaneous Infusion System for Remodulin	QJY	Substantially Equivalent	DEKA Research & Development	accessdata.fda.gov

Compare with other makers

Updated August 1, 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.