BEUDAMED
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    ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

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

    HARDYDISK, VANCOMYCIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CEDARS-SINAI BPGS AND MOCO

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DTK·August 21, 2014

    UNK

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DTK·August 20, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·August 20, 2014

    DELTA CER HEAD 11/13 32MM +3

    FDA Adverse Event
    Injury ·DEPUY IRELAND ? REG. # 9616671·Product code LZO·April 8, 2013

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE·Product code MKJ·July 7, 2014

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·April 6, 2011

    GUNTHER TULIP VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·April 3, 2026

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·December 5, 2017

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DTK·November 1, 2017

    GUNTHER TULIP VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·November 4, 2025

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 27, 2018

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·May 5, 2017

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DTK·May 12, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 3, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 1, 2018