BEUDAMED
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    VisAR

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540259127·SCREWDRIVER BLADE, HEXAGON

    CultureSwab

    FDA UDI
    COPAN ITALIA SPA·38053326002107·140CQ TRANS.LQ AMIES CultureSwab Polyester Liqu...

    BD ULTRA-FINE¿ INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 8, 2023

    LINK Instruments - Saw and drill guides

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575341443·Orthopaedic implant aiming/guiding block, reusa...

    QUARK SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SERRALNYL

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

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·August 6, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 15, 2011

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    LAPIPLASTY SYSTEM S4A

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025

    EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·November 27, 2019

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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