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    HMS-DHR-3 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    HMS-DHR-3 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PAR - 1 HR REFIL, 50ML DHR, CLOSED TIP CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC PS MEDICAL·Product code LKK·July 15, 1998

    PAR - 1 HR REFILL, 50ML DHR, CLOSED TIP CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC PS MEDICAL·Product code LKK·October 7, 1998

    PAR - 1 HR REFILL, 50 ML DHR, CLOSED TIP CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC PS MEDICAL·Product code LKK·October 7, 1998

    Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

    FDA Enforcement
    Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRG·May 15, 2017

    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·September 20, 2017

    4.75 HEALIX ADVANCE KNTLSS BR

    FDA Adverse Event
    Malfunction ·A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COND·Product code MAI·January 29, 2019

    IMMAGE® RHEUMATOID FACTOR REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·January 30, 2012

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·January 13, 2012

    IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·January 5, 2012

    IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·January 26, 2012

    IMMAGE RHEUMATOID FACTOR (RF)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·February 3, 2012

    IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·January 8, 2012

    IMMAGE® RHEUMATOID FACTOR REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·March 21, 2012

    IMMAGE® RHEUMATOID FACTOR REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·January 30, 2012

    SYNCHRON SYSTEMS RHEUMATOID FACTOR REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·March 12, 2012

    IMMAGE® RHEUMATOID FACTOR REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·January 6, 2012