BEUDAMED
    54 results · 27ms · 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 ×

    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

    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

    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·May 7, 2021

    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·May 7, 2021

    Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part Number: A54378, UniCel DxC 600i APF, Part Number: A54379, UniCel DxC 600i AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·September 11, 2008

    Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·September 11, 2008

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Recall
    Terminated ·X-NAV Technologies, LLC·Product code PLV·February 23, 2016

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·September 28, 2022

    Lodox Statscan digital radiographic system.

    FDA Recall
    Terminated ·Lodox Na Llc·May 10, 2004

    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

    ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code CAF·March 31, 2021

    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CAF·November 16, 2015

    Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.

    FDA Recall
    Terminated ·SANRAI INTERNATIONAL LLC·Product code CAF·August 29, 2018

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Recall
    Terminated ·Aerogen Ltd. Galway Business Park Dangan Galway Ireland·Product code CAF·September 2, 2014

    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.

    FDA Recall
    Terminated ·Compass Health Brands·Product code CAF·April 20, 2015