BEUDAMED
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    COBAS REAGENT FOR BUN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517137951·Helix R Screw, 4x16mm Var Self-Drill

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668117507·Bechert-McPherson Tying Forceps, Angled

    BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G-IVF G5 SERIES

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

    CATHETER MOUNT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·May 8, 2014

    SPINAL ANES/EPIDURAL CAT H KIT

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code CAZ·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024