BEUDAMED
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    ULTRASTAT NASAL CATHETER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517173676·VuePoint Screw, 3.5x10mm Polyaxial Tulip

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118196·

    ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 23, 2015

    BI-METRIC HA/PC 13X145MM (T1)

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·June 30, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·November 17, 2010

    MEDSYSTEM III INFUSION PUMP

    FDA Adverse Event
    Injury ·CAREFUSION CORP.·Product code FRN·December 20, 2012

    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·December 12, 2018

    DBB-06 Hemodialysis Delivery System

    FDA Recall
    Open, Classified ·Nikkiso Ltd Shizuoka Plant 498 1 Shizutani; Shizuoka-Ken Makinohara Japan·Product code KDI·November 24, 2021

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021