BEUDAMED
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    BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607276·SKYTRON 3501B 4" SOFTCARE

    RHIGENE MESACUP2 TEST- SCL-70

    FDA 510(k)
    FDA Class 2 ·Immunology

    PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

    FDA 510(k)
    FDA Class 2 ·Hematology

    ECO HME

    FDA UDI
    GVS Technology (Suzhou) Co., Ltd.·15060120952650·

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2013

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·May 6, 2011

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO. MED REL·Product code LGW·July 23, 2008

    INFINION CX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 26, 2023

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·September 4, 2025

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024