BEUDAMED
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    ENNOVATE®

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868240041·

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304555204·

    MSI

    FDA UDI
    Modern Surgical Instruments LLC·00810130201150·Lid for Tray RS without lock

    ANDREWS PYNCHON SUCTION

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896000513·ANDREWS PYNCHON SUCTION STAINLESS STEEL

    ANDREWS PYNCHON SUCTION

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991804330·ANDREWS PYNCHON SUCTION STAINLESS STEEL

    JMS SYSLOC APHERESIS NEEDLE SET

    FDA UDI
    JMS SINGAPORE PTE LTD·08888483005444·SYSLOC APHERESIS 18GX1" BE 30CM W/CLAMP

    Block Pusher

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215064082·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971307·

    CLEARBLUE EASY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    INSPIRE 6F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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