4,836 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEOBASE NON-DERIVATIZED MSMS KIT
FDA Adverse Event
Malfunction
·WALLAC OY·Product code NQL·November 26, 2012
NEOBASE NON-DERIVATIZED MSMS KIT
FDA Adverse Event
Malfunction
·PERKINELMER, WALLAC OY·Product code NQL·December 12, 2014
NEOBASE¿ 2 NON-DERIVATIZED MSMS KIT
FDA Adverse Event
Malfunction
·WALLAC OY·Product code NQL·April 29, 2025
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
FDA Recall
Terminated
·Perkinelmer·Product code NQL·November 26, 2012
Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
FDA Recall
Terminated
·Perkin Elmer Life And Analytical·Product code NQL·March 11, 2005
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
FDA classification
FDA Class 2
·System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
N/Al
FDA UDI
PENTAX OF AMERICA, INC.·04961333231157·SOFTWARE KEY, USB HASP-4
NML Medical, LLC
FDA registration
NML Medical, LLC·17 products·🇺🇸 United States
NTL HEALTHCARE CO., LTD.
FDA registration
NTL HEALTHCARE CO., LTD.·1 product·🇰🇷 South Korea
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
Ke-Nal Hosiery Sa De Cv
FDA registration
Ke-Nal Hosiery Sa De Cv·1 product·🇲🇽 Mexico
Aquilex® Fluid Control System
FDA UDI
W.O.M. World of Medicine GmbH·04056702002121·
Tube set for vacuum, reusable
FDA UDI
W.O.M. World of Medicine GmbH·04056702002244·
Aquilex Fluid Control System
FDA UDI
W.O.M. World of Medicine GmbH·04056702006914·
Aquilex® Fluid Control System
FDA UDI
W.O.M. World of Medicine GmbH·04056702006556·
Aquilex® Fluid Control System
FDA UDI
W.O.M. World of Medicine GmbH·04056702002145·
Aquilex Fluid Control System
FDA UDI
BEMIS MANUFACTURING COMPANY·10073088152999·Kit containing 36-3000cc canister with aerostat...
Tube set for irrigation, single-use
FDA UDI
W.O.M. World of Medicine GmbH·04056702002152·
Tube set for suction, single-use
FDA UDI
W.O.M. World of Medicine GmbH·04056702002190·