BEUDAMED
    39 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    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

    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

    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 Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 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 Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 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 Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 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 Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 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 Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    FDA Recall
    Open, Classified ·Young Dental Manufacturing I, LLC·Product code LBH·May 23, 2023

    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

    FDA Recall
    Completed ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JWH·April 26, 2023

    Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003

    Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code FRN·November 30, 2022

    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 Recall
    Terminated ·Ultradent Products, Inc.·Product code LBH·July 12, 2018

    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.

    FDA Recall
    Terminated ·Medela Inc. EF Division·Product code FMF·February 13, 2015

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Recall
    Terminated ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012

    COBAS TaqMan analyzer, Series 96; catalog number 8080216.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·March 6, 2003

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    Cytomics FC500 with CXP Software

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JJF·November 23, 2005

    COBAS TaqMan 48 Analyzers.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·May 24, 2004

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Recall
    Open, Classified ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 18, 2016