BEUDAMED
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    THE O'NEIL STERILE FIELD URINARY CATHETER KIT

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450266212·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450169636·

    4.0 X 28mm CANN SCREW FASTENER Ti FL THD

    FDA UDI
    Osteocentric Technologies, Inc.·00810074304696·4.0 X 28mm CANN SCREW FASTENER Ti FL THD

    HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCELERATOR RECIPROCATING CANNULA

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

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016

    LIBERTE MONORAIL CORONARY STENT DEL SYS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MAF·November 14, 2006

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 17, 2018

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·March 13, 2013

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·February 26, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018