467 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Neoscope
FDA UDI
PROSURG INC·00851545007562·NEOFLEX- FLEXIBLE VIDEO BRONCHOSCOPE
Neoscope
FDA UDI
PROSURG INC·00851545007579·NEOFLEX - FLEXIBLE VIDEO BRONCHOSCOPE
NBF 10% NEUTRAL BUFFERED FORMALIN
FDA 510(k)
FDA Class 1
·Pathology
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS MELBOURNE PTY.LTD·Product code IEO·March 8, 2018
BIOPSY PADS 1 X 1.25, BLUE
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS RICHMOND, INC.·Product code IEO·February 6, 2014
Rad-Sure™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065444·Blood Irradiation Indicator
Rad-Sure™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00810106410289·Blood Irradiation Indicator
PD-L1 SP263
FDA Adverse Event
Injury
·VENTANA MEDICAL SYSTEMS INC·Product code PLS·July 14, 2017
Rad-Sure™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00810106410340·Blood Irradiation Indicator
Rad-Sure™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065482·Blood Irradiation Indicator
Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE
FDA Adverse Event
Injury
·RICHARD ALLAN SCIENTIFIC·Product code IFP·October 22, 2019
Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014