BEUDAMED
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    RESTEP DVY SYSTEM, MODEL RSP-101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036028602·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024038·Paddle Shaver, 8mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103080·Shaver, Closed, 8mm

    REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE

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

    WALLSTENT BILIARY ENDOPROSTHESIS

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·May 2, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 16, 2011

    Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

    FDA Recall
    Open, Classified ·Hamilton Medical AG via Crusch 8 Bonaduz Switzerland·Product code CBK·March 12, 2018

    Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

    FDA Recall
    Open, Classified ·Hamilton Medical AG via Crusch 8 Bonaduz Switzerland·Product code CBK·March 12, 2018

    Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.

    FDA Recall
    Terminated ·Hamilton Medical, Inc.·Product code CBK·September 26, 2016

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014