BEUDAMED
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    K-ASSAY CRP CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517676832·Monolith Core, Ø12x10mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198949·AK3 Congruent Insert Trial Size 2, 10mm

    ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Longeviti ClearFit Cranial Implant

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 4, 2018

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 31, 2018

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 3, 2018

    PREMIER ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

    S-ROM M HEAD 36MM -3

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code JDI·March 6, 2013

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·February 15, 2011

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·August 8, 2014

    BIOMET MAXIM FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 15, 2018

    VANGUARD STABALIZED BEARING 18X75

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 15, 2018

    BIOMET CC CRUCIATE TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 15, 2018

    Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFT·August 3, 2009

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024