16 results
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7ms
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Sources: EU EUDAMED, US FDA
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Enforcement
Class II
·Ongoing·KOB GmbH·March 18, 2026
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·January 21, 2026
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·December 10, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·October 4, 2023
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·November 5, 2025
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025
BD Kiestra" ReadA; Catalog No.: 446948.
FDA Enforcement
Class II
·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014