BEUDAMED
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    SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143541·

    Endo-Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964013087·Endo Carry-on Procedur Kit contains all of the ...

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001454·artVeneer life lower anteriors, UBM, D2

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·February 24, 2014

    INFINION PRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2024

    DIMEX 2

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 26, 2019

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 5, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·February 25, 2011

    VICKS

    FDA Adverse Event
    Other ·KAZ, INC.·Product code KFZ·February 15, 2008

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017