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    MAGNETOM SKYRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    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

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540492012·LOCKING SCREW, CROSS-PIN

    CASTROVIEJO CYCLODIALYSIS SPATULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896013445·CASTROVIEJO CYCLODIALYSIS SPATULA DOUBLE ENDED ...

    iTotal Identity 3DP Porous Knee

    FDA UDI
    Restor3d, Inc.·00840097515113·iTotal Identity 3DP Porous Round Patella 35mm x...

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210166438·Polyaxial Screw, 3.5mm x 10mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376657066·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 10mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040703·Screw - Self-Drilling - 3.5x10mm

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052324·3.5mm x 10mm Poly Screw Assm. The Atoll OCT Spi...

    TRUTEK SELECT MODEL TT-1001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    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

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376669250·12mm CORE, NANOTEC KBN 12 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376668628·12mm CORE, NANOTEC BAN 12 x 35 mm 10°

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·May 22, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PURMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    INSYNC MAXIMO

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·June 14, 2011

    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