BEUDAMED
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    VENTROFIL TENSION RELIEF SUTURE SET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515230644·Bellucci Wullstein Ret, left, solid bld right

    GASTROINTESTINAL CYTOLOGY BRUSH

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

    ACSYS SHEARER ACETABULAR CUP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    UNSPECIFIED CENTRAL LINE CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.,·Product code CBK·May 28, 2014

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 22, 2010

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 30, 2012

    94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017