Data / Medical devices / United States / Ecomed Solutions, LLC

Ecomed Solutions, LLC: FDA-registered device maker in Lindenhurst, IL, United States, 10 510(k) clearances

Name: Ecomed Solutions, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ecomed Solutions, LLC is registered with the FDA (registration 3010934635) in Lindenhurst, IL, United States. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010934635
Address: 2910 Falling Waters Blvd, Lindenhurst, IL, United States, 60046
Owner or operator: Ecomed Solutions, LLC (10049951)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 11, 2015
Registered through: 2027
Brand names listed: HEMAsavR, Sureglide

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Reservoir, Blood, Cardiopulmonary Bypass, Exempt	PTN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, Blood Transfusion	BRZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Complaint file establishment, Specification developer	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
December 22, 2023	K232881	Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder	JKA	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.	accessdata.fda.gov
March 23, 2023	K212207	Sterile Hypodermic Syringe for Single Use	FMF	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.	accessdata.fda.gov
January 17, 2018	K170234	Endotracheal tube; Reinforced Endotracheal tube	BTR	Substantially Equivalent	Zhanjiang Star Enterprise Co., Ltd.	accessdata.fda.gov
January 27, 2017	K162088	Ecomed Disposable Angiographic Syringes	DXT	Substantially Equivalent	Ecomed Solutions, LLC	accessdata.fda.gov
April 15, 2011	K110921	NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS	LZA	Substantially Equivalent	Cardinal Health, Inc.	accessdata.fda.gov
August 7, 2009	K083429	I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT	FOZ	Substantially Equivalent	Weihai Jierui Medical Products Co., Ltd.	accessdata.fda.gov
June 11, 2009	K090012	DISPOSABLE INFUSION SET	FPA	Substantially Equivalent	Shan Dong Wei Gao Group Medical Polymer Products	accessdata.fda.gov
April 10, 2009	K083349	BLOOD TRANSFUSION SET	BRZ	Substantially Equivalent	Shan Dong Wei Gao Group Medical Polymer Products	accessdata.fda.gov
March 23, 2009	K082439	DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT	DXT	Substantially Equivalent	Shandong Weigao Medical Polymer Co., Ltd.	accessdata.fda.gov
March 21, 2008	K072739	JIERUI SYRINGES AND NEEDLES	MEG	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 22, 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.