14 results
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11ms
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Sources: EU EUDAMED, US FDA
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
FDA Enforcement
Class II
·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·January 12, 2022
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·May 12, 2021
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Enforcement
Class II
·Terminated·Centers For Disease Control and Prevention·July 3, 2024