BEUDAMED
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    Ultrasonic Doppler (Model YM-2T8)

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

    D-Pad Impactor

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215064068·

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·July 25, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 24, 2024

    OPEN SPINE CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·February 24, 2026

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MGB·July 27, 2011

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 20, 2013

    MED-EL MAESTRO COCHLEAR IMPLANT SYS

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·October 15, 2014

    GALAXY G3 XSFT HEL 2MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·February 16, 2021

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·December 10, 2019

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·July 31, 2019

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019