BEUDAMED
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    iBalance UKA Tibial Tray Implant

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III

    KeyPrint

    FDA UDI
    Keystone Industries·H66842004331·KeyDenture Base Light Pink 0.5kg

    Intraoral Scan Body RP

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075137·

    LAHEY-SWEET HEMOSTATIC FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060883·LAHEY-SWEET HEMOSTATIC FORCEPS CURVED LONGITUDI...

    PBN HYSTERO-SALPINGOGRAPHY CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 12, 2023

    ACCU-CHEK TENDER INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FPA·July 14, 2010

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 1, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·September 5, 2012

    ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code OVE·June 9, 2017

    INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.

    FDA Enforcement
    Class I ·Terminated·Alere San Diego, Inc.·January 14, 2015

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    FDA Enforcement
    Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

    Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.

    FDA Enforcement
    Class I ·Terminated·Alere San Diego, Inc.·August 31, 2016

    Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio2 PT/INR Home Monitoring System is not intended to be used for screening purposes.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

    INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·December 5, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014