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Globalmed Logistix LLC: FDA-registered device maker in Norcross, GA, United States, 3 510(k) clearances

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

Globalmed Logistix LLC is registered with the FDA (registration 3006053983) in Norcross, GA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 21, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006053983
Address: 1880 Beaver Ridge Cir, Norcross, GA, United States, 30071
Owner or operator: Globalmed Logistix LLC (10049197)
Roles: Repackager or relabeler
First device listed: October 9, 2015
Registered through: 2026
Brand names listed: Lipogems System, MagnetOs Flex Matrix

Devices it lists

Device	Product code	Class	Role	Source
Filler, Bone Void, Calcium Compound	MQV	2	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
System, Suction, Lipoplasty	MUU	2	Repackager or relabeler	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
November 21, 2023	K233245	MagnetOs Flex Matrix	MQV	Substantially Equivalent	Kuros Biosciences B.V	accessdata.fda.gov
April 14, 2022	K213959	MagnetOs Flex Matrix	MQV	Substantially Equivalent	Kuros Biosciences B.V	accessdata.fda.gov
December 22, 2014	K142682	The Lipogems System	MUU	Substantially Equivalent	Lipogems International Spa	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 15, 2015	72904	Class II	Terminated	Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.	The cannulae may bend during procedure.	accessdata.fda.gov

Compare with other makers

Updated November 21, 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.