BEUDAMED
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    Auto Lung Nodule Detection

    FDA 510(k)
    FDA Class 2 ·Radiology

    16PW - Krispy Kreme FAK - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113578·PRESET 600 MICRON KNIFE (BX/5)

    BTP-1000L-2 BTI

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146BTPL210·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450273081·

    MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ODONTOSURGE 3

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·August 5, 2020

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 30, 2024

    X-STOP INTERSPINOUS SPACER SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NQO·May 19, 2017

    X-STOP INTERSPINOUS SPACER SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NQO·May 19, 2017

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·October 16, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    LAMITRODE S8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 28, 2013

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    FDA Adverse Event
    Malfunction ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·September 22, 2015

    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

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    ADV MULTIPLANAR CLAMP

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code JDW·July 22, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 23, 2023