BEUDAMED
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    KITAZATO OPU NEEDLE

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

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...

    InnoSpire Essence

    FDA UDI
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730002248·Innospire Essence, Custom Medicate Pharmacy FR,...

    STANDARD RIGID TIP SUCTION WAND

    FDA Adverse Event
    Malfunction ·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code DTS·September 13, 2012

    SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    THEKEN LARGE CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 28, 2011

    Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.

    FDA Enforcement
    Class II ·Terminated·California Medical Laboratories Inc·January 16, 2013

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025