10 results
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10ms
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Sources: EU EUDAMED, US FDA
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
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
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
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 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
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Variety Pack REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Product Usage: Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
FDA Enforcement
Class II
·Terminated·Ultradent Products, Inc.·January 9, 2019