BEUDAMED
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    Dermatological diode laser system

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Oticon

    FDA UDI
    Oticon A/S·05707131376152·OPN S 1, MINIRITE 312 2.4G NFM PB C092

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586040221·

    VISI MOBILE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEEDLE 27GA 1-1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·April 1, 2025

    NEEDLE 27GA 1-1/2IN

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMI·February 26, 2025

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    530G INSULIN PUMP MMT-551NAP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 25, 2014

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

    Unity Total Knee System. Used for knee prosthesis in total knee replacement

    FDA Recall
    Terminated ·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·October 31, 2022

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 5, 2022

    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023