BEUDAMED
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    Powder Free Polychloroprene Examination Glove Green

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707015024·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 10

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111085611·SKLARCUT OP SCIS CVD SS 5 1/2

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507592·Gutta Percha Points is used to root canal filin...

    IR WIRELESS FOOT SWITCH

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

    UNIMAX SPECIMEN RETRIEVAL SYSTEM

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

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·April 12, 2018

    CURRENT PLUS VR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code MQR·August 17, 2017

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·March 15, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·November 12, 2014

    T2 STRATOSPHERE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·September 7, 2020