BEUDAMED
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    MICRUS COURIER ENZO MICROCATHETER 0.017

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOSCANNER CREATININE TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PURACOL PLUS COLLAGEN WOUND DRESSING

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, LP·Product code KGN·April 16, 2026

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·April 22, 2013

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 29, 2011

    URISYS 2400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JIL·July 7, 2008

    SAVARY-GILLIARD DILATOR SET

    FDA Adverse Event
    Death ·COOK ENDOSCOPY·Product code KNQ·October 22, 2019

    SAVARY-GILLIARD DILATOR SET

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KNQ·October 23, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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